Ignite Creation Date:
2025-12-25 @ 3:46 AM
Ignite Modification Date:
2026-02-25 @ 8:31 PM
Study NCT ID:
NCT02165202
Status:
COMPLETED
Last Update Posted:
2018-08-27
First Post:
2014-05-21
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Phase II Safety and Acceptability of an Investigational Injectable Product, TMC278LA, for Pre-Exposure Prophylaxis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000163', 'term': 'Acquired Immunodeficiency Syndrome'}], 'ancestors': [{'id': 'D015658', 'term': 'HIV Infections'}, {'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D016180', 'term': 'Lentivirus Infections'}, {'id': 'D012192', 'term': 'Retroviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D012897', 'term': 'Slow Virus Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068696', 'term': 'Rilpivirine'}], 'ancestors': [{'id': 'D009570', 'term': 'Nitriles'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'hkelly@path.org', 'phone': '650-392-2510', 'title': 'Heather Kelly', 'organization': 'PATH'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Adverse Event data were collected from the time of enrollment to the end of the study. (From enrollment to week 76).', 'description': 'Adverse Event data that were collected during injection phase from the time of first injection to week 52 are included in the Report showing list of other AEs excluding Serious AEs. (From week 4 to week 52).', 'eventGroups': [{'id': 'EG000', 'title': 'Rilpivirine', 'description': "Arm 1: Participants randomized to the active arm will receive rilpivirine 25 mg capsules once daily for four weeks to be taken orally with a meal. Participants will then receive IM injections of TMC278 LA, 1200 mg dose, at eight week intervals (at Weeks 4, 12, 20, 28, 36 and 44). On each dosing occasion 1200 mg of TMC278 LA will be delivered in two, 2 mL injections, one in each gluteus maximus muscle. All participants will receive a total of six doses (12 IM injections).\n\nRilpivirine: Rilpivirine (TMC278), a non-nucleoside reverse transcriptase inhibitor (NNRTI) is a substituted diaryl-pyrimidine (DAPY) derivative with potent antiviral activity against HIV. It is approved by the US FDA for once daily oral administration and is effective as part of treatment for ARV-na'ive HIV-infected patients as rilpivirine 25 mg capsules. It is also co-formulated with TDF and FTC for use as a once- daily single fixed-dose combination (Complera™).", 'otherNumAtRisk': 80, 'deathsNumAtRisk': 91, 'otherNumAffected': 80, 'seriousNumAtRisk': 91, 'deathsNumAffected': 1, 'seriousNumAffected': 4}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Arm 2: Participants randomized to the placebo arm will receive placebo capsules once daily for four weeks to be taken orally with a meal. Participants will then receive IM injections of saline (0.9% NaCI) at eight week intervals (at Weeks 4, 12, 20, 28, 36 and 44). On each dosing occasion placebo will be delivered in two, 2 mL injections, one in each gluteus maximus muscle. All participants will receive a total of six doses (12 IM injections).\n\nPlacebo: Participants randomized to the placebo arm will receive oral placebo capsules prior to injection of saline solution (0.9%NaCI). Participants will be observed while taking the study product by site staff on approximately six occasions during the first two weeks of the oral run-in at Week 0 (Enrollment), at Week 2 (Oral Run-in Safety Visit), and on four separate DOT visits between Weeks 0 and 2. Cervicovaginal and rectal fluid will be collected for PK studies at a single follow-up visit.', 'otherNumAtRisk': 42, 'deathsNumAtRisk': 45, 'otherNumAffected': 40, 'seriousNumAtRisk': 45, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Lymphadenopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Sinus arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Ear pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Ear pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Hyperthyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Chalazion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Conjunctival haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Eye pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Visual acuity reduced', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Abdominal pain lower', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Aphthous ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Haemorrhoids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Feeling hot', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Induration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Influenza like illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Injection site discharge', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Injection site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 20, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Injection site granuloma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Injection site haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Injection site induration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Injection site inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Injection site mass', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Injection site nodule', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Injection site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 60, 'numAffected': 60}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 17, 'numAffected': 17}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Injection site pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 29, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Injection site swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 29, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Nodule', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Biliary colic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Cholestasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Hepatic steatosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Seasonal allergy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Bacterial vaginosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Body tinea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Carbuncle', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Dermatophytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Genital herpes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Genitourinary chlamydia infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Groin abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Helminthic infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}], 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and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Macule', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Night sweats', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Psoriasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Rash macular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Rash maculo-papular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Rash papular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Skin discolouration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Skin ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Vaginal odour', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Vulvovaginal pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}], 'seriousEvents': [{'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Haemorrhagic stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Overdose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Radius fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Pelvic fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Pancreatitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Pancreatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Nephrolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants Experiencing Any Grade 2 or Higher AEs During Injection Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rilpivirine', 'description': "Arm 1: Participants randomized to the active arm will receive rilpivirine 25 mg capsules once daily for four weeks to be taken orally with a meal. Participants will then receive IM injections of TMC278 LA, 1200 mg dose, at eight week intervals (at Weeks 4, 12, 20, 28, 36 and 44). On each dosing occasion 1200 mg of TMC278 LA will be delivered in two, 2 mL injections, one in each gluteus maximus muscle. All participants will receive a total of six doses (12 IM injections).\n\nRilpivirine: Rilpivirine (TMC278), a non-nucleoside reverse transcriptase inhibitor (NNRTI) is a substituted diaryl-pyrimidine (DAPY) derivative with potent antiviral activity against HIV. It is approved by the US FDA for once daily oral administration and is effective as part of treatment for ARV-na'ive HIV-infected patients as rilpivirine 25 mg capsules. It is also co-formulated with TDF and FTC for use as a once- daily single fixed-dose combination (Complera™)."}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Arm 2: Participants randomized to the placebo arm will receive placebo capsules once daily for four weeks to be taken orally with a meal. Participants will then receive IM injections of saline (0.9% NaCI) at eight week intervals (at Weeks 4, 12, 20, 28, 36 and 44). On each dosing occasion placebo will be delivered in two, 2 mL injections, one in each gluteus maximus muscle. All participants will receive a total of six doses (12 IM injections).\n\nPlacebo: Participants randomized to the placebo arm will receive oral placebo capsules prior to injection of saline solution (0.9%NaCI). Participants will be observed while taking the study product by site staff on approximately six occasions during the first two weeks of the oral run-in at Week 0 (Enrollment), at Week 2 (Oral Run-in Safety Visit), and on four separate DOT visits between Weeks 0 and 2. Cervicovaginal and rectal fluid will be collected for PK studies at a single follow-up visit.'}], 'classes': [{'categories': [{'measurements': [{'value': '59', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 52 weeks', 'description': 'Number of participants experiencing any Grade 2 or higher clinical and laboratory AEs to evaluate the safety of the injectable product, TMC278 LA (1200 mg dose administered at Weeks 4, 12, 20, 28, 36 and 44), through 48 weeks after initial injection (at Week 52) in women in SSA and the US.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who received at least one injection and were followed up to 52 weeks are included in this analysis.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Rilpivirine', 'description': "Arm 1: Participants randomized to the active arm will receive rilpivirine 25 mg capsules once daily for four weeks to be taken orally with a meal. Participants will then receive IM injections of TMC278 LA, 1200 mg dose, at eight week intervals (at Weeks 4, 12, 20, 28, 36 and 44). On each dosing occasion 1200 mg of TMC278 LA will be delivered in two, 2 mL injections, one in each gluteus maximus muscle. All participants will receive a total of six doses (12 IM injections).\n\nRilpivirine: Rilpivirine (TMC278), a non-nucleoside reverse transcriptase inhibitor (NNRTI) is a substituted diaryl-pyrimidine (DAPY) derivative with potent antiviral activity against HIV. It is approved by the US FDA for once daily oral administration and is effective as part of treatment for ARV-na'ive HIV-infected patients as rilpivirine 25 mg capsules. It is also co-formulated with TDF and FTC for use as a once- daily single fixed-dose combination (Complera™)."}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Arm 2: Participants randomized to the placebo arm will receive placebo capsules once daily for four weeks to be taken orally with a meal. Participants will then receive IM injections of saline (0.9% NaCI) at eight week intervals (at Weeks 4, 12, 20, 28, 36 and 44). On each dosing occasion placebo will be delivered in two, 2 mL injections, one in each gluteus maximus muscle. All participants will receive a total of six doses (12 IM injections).\n\nPlacebo: Participants randomized to the placebo arm will receive oral placebo capsules prior to injection of saline solution (0.9%NaCI). Participants will be observed while taking the study product by site staff on approximately six occasions during the first two weeks of the oral run-in at Week 0 (Enrollment), at Week 2 (Oral Run-in Safety Visit), and on four separate DOT visits between Weeks 0 and 2. Cervicovaginal and rectal fluid will be collected for PK studies at a single follow-up visit.'}], 'periods': [{'title': 'Oral Phase', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Participants Enrolled in the study', 'groupId': 'FG000', 'numSubjects': '91'}, {'comment': 'Participants Enrolled in the study', 'groupId': 'FG001', 'numSubjects': '45'}]}, {'type': 'COMPLETED', 'comment': 'Participants who completed oral run in phase (0-week 4) and received at least 1 injection.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '80'}, {'groupId': 'FG001', 'numSubjects': '42'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Refused further participation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Study product Related Toxicity', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Unable to contact Participant', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Clinical reasons', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'QTcF>500 ms or increase of>60 ms', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'CMC advised termination', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Relocated, no follow-up planned', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Abnormal EKG', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}, {'title': 'Injection Phase', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Participants who received at least one injection.', 'groupId': 'FG000', 'numSubjects': '80'}, {'comment': 'Participants who received at least one injection.', 'groupId': 'FG001', 'numSubjects': '42'}]}, {'type': 'COMPLETED', 'comment': 'Ppts who received at least 1 injection but were not discontinued or terminated till the end of study', 'achievements': [{'groupId': 'FG000', 'numSubjects': '70'}, {'groupId': 'FG001', 'numSubjects': '36'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '6'}]}], 'dropWithdraws': [{'type': 'Abnormal Lab Value', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Reactive HIV or HIV Suspected', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Unable to attend within Visit Window', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'QTcF>500 ms or increase of>60 ms', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'End of Study', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Study Product related Toxicity', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'No longer interested', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Participant unwilling to comply', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'Participants will be randomized to either the active product regimen or the placebo arm at enrollment. Participants randomized to active and placebo product will first be prescribed oral TMC278 (rilpivirine) 25 mg capsule and oral placebo capsule, once daily for four weeks as an oral run-in and then will receive IM injections at week 4.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '136', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Rilpivirine', 'description': "Arm 1: Participants randomized to the active arm will receive rilpivirine 25 mg capsules once daily for four weeks to be taken orally with a meal. Participants will then receive IM injections of TMC278 LA, 1200 mg dose, at eight week intervals (at Weeks 4, 12, 20, 28, 36 and 44). On each dosing occasion 1200 mg of TMC278 LA will be delivered in two, 2 mL injections, one in each gluteus maximus muscle. All participants will receive a total of six doses (12 IM injections).\n\nRilpivirine: Rilpivirine (TMC278), a non-nucleoside reverse transcriptase inhibitor (NNRTI) is a substituted diaryl-pyrimidine (DAPY) derivative with potent antiviral activity against HIV. It is approved by the US FDA for once daily oral administration and is effective as part of treatment for ARV-na'ive HIV-infected patients as rilpivirine 25 mg capsules. It is also co-formulated with TDF and FTC for use as a once- daily single fixed-dose combination (Complera™)."}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Arm 2: Participants randomized to the placebo arm will receive placebo capsules once daily for four weeks to be taken orally with a meal. Participants will then receive IM injections of saline (0.9% NaCI) at eight week intervals (at Weeks 4, 12, 20, 28, 36 and 44). On each dosing occasion placebo will be delivered in two, 2 mL injections, one in each gluteus maximus muscle. All participants will receive a total of six doses (12 IM injections).\n\nPlacebo: Participants randomized to the placebo arm will receive oral placebo capsules prior to injection of saline solution (0.9%NaCI). Participants will be observed while taking the study product by site staff on approximately six occasions during the first two weeks of the oral run-in at Week 0 (Enrollment), at Week 2 (Oral Run-in Safety Visit), and on four separate DOT visits between Weeks 0 and 2. Cervicovaginal and rectal fluid will be collected for PK studies at a single follow-up visit.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '136', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '31', 'groupId': 'BG000', 'lowerLimit': '26', 'upperLimit': '36'}, {'value': '30', 'groupId': 'BG001', 'lowerLimit': '25', 'upperLimit': '39'}, {'value': '31', 'groupId': 'BG002', 'lowerLimit': '25', 'upperLimit': '38'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '136', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '91', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '136', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '136', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '85', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '127', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '136', 'groupId': 'BG002'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '86', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '128', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '136', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}]}, {'title': 'Zimbabwe', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '136', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}]}]}, {'title': 'South Africa', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '136', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Categorical', 'classes': [{'title': '18-25', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '136', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}]}, {'title': '26-35', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '136', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '45', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '59', 'groupId': 'BG002'}]}]}, {'title': '36-45', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '136', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Height', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '136', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '159', 'groupId': 'BG000', 'lowerLimit': '153', 'upperLimit': '165'}, {'value': '158', 'groupId': 'BG001', 'lowerLimit': '152', 'upperLimit': '165'}, {'value': '158', 'groupId': 'BG002', 'lowerLimit': '153', 'upperLimit': '165'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'cm', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Weight', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '135', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '76', 'groupId': 'BG000', 'lowerLimit': '67', 'upperLimit': '89'}, {'value': '73', 'groupId': 'BG001', 'lowerLimit': '63', 'upperLimit': '88'}, {'value': '75', 'groupId': 'BG002', 'lowerLimit': '64', 'upperLimit': '89'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'kg', 'dispersionType': 'INTER_QUARTILE_RANGE', 'populationDescription': '1 participant was missing weight measurement'}, {'title': 'BMI', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '135', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '31', 'groupId': 'BG000', 'lowerLimit': '26', 'upperLimit': '35'}, {'value': '29', 'groupId': 'BG001', 'lowerLimit': '27', 'upperLimit': '35'}, {'value': '30', 'groupId': 'BG002', 'lowerLimit': '27', 'upperLimit': '35'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'INTER_QUARTILE_RANGE', 'populationDescription': '1 participant was missing BMI'}, {'title': 'Marital Status', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '136', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Married/civil union/legal partnership', 'measurements': [{'value': '45', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '63', 'groupId': 'BG002'}]}, {'title': 'Living with primary or main partner', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': 'Have primary or main partner, not living', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}, {'title': 'Single/divorced/widowed', 'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}]}, {'title': 'Other', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Employment Status', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '136', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Not employed', 'measurements': [{'value': '60', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '82', 'groupId': 'BG002'}]}, {'title': 'Part-time employment', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}, {'title': 'Full-time employment', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Education', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '136', 'groupId': 'BG002'}]}], 'categories': [{'title': 'No schooling', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Primary school, not complete', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}, {'title': 'Primary school, complete', 'measurements': [{'value': '58', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '85', 'groupId': 'BG002'}]}, {'title': 'Secondary school, not complete', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}, {'title': 'Secondary school, complete', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}, {'title': 'Technical training, not complete', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Technical training, complete', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'College or university, not complete', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'College or university, complete', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'This template shows demographic characteristics of participants measured at Enrollment in the study.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 136}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2017-03-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-07-27', 'studyFirstSubmitDate': '2014-05-21', 'resultsFirstSubmitDate': '2018-07-02', 'studyFirstSubmitQcDate': '2014-06-13', 'lastUpdatePostDateStruct': {'date': '2018-08-27', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-07-02', 'studyFirstPostDateStruct': {'date': '2014-06-17', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-07-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-04-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants Experiencing Any Grade 2 or Higher AEs During Injection Phase', 'timeFrame': 'Up to 52 weeks', 'description': 'Number of participants experiencing any Grade 2 or higher clinical and laboratory AEs to evaluate the safety of the injectable product, TMC278 LA (1200 mg dose administered at Weeks 4, 12, 20, 28, 36 and 44), through 48 weeks after initial injection (at Week 52) in women in SSA and the US.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['HIV Pre-exposure Prophylaxis;', 'long-acting injectable;', 'HIV PrEP;', 'biomedical HIV prevention research'], 'conditions': ['Human Immunodeficiency Virus (HIV)']}, 'referencesModule': {'references': [{'pmid': '22908192', 'type': 'BACKGROUND', 'citation': 'Bekker LG, Beyrer C, Quinn TC. Behavioral and biomedical combination strategies for HIV prevention. Cold Spring Harb Perspect Med. 2012 Aug 1;2(8):a007435. doi: 10.1101/cshperspect.a007435.'}, {'pmid': '23769234', 'type': 'BACKGROUND', 'citation': 'Choopanya K, Martin M, Suntharasamai P, Sangkum U, Mock PA, Leethochawalit M, Chiamwongpaet S, Kitisin P, Natrujirote P, Kittimunkong S, Chuachoowong R, Gvetadze RJ, McNicholl JM, Paxton LA, Curlin ME, Hendrix CW, Vanichseni S; Bangkok Tenofovir Study Group. Antiretroviral prophylaxis for HIV infection in injecting drug users in Bangkok, Thailand (the Bangkok Tenofovir Study): a randomised, double-blind, placebo-controlled phase 3 trial. Lancet. 2013 Jun 15;381(9883):2083-90. doi: 10.1016/S0140-6736(13)61127-7. Epub 2013 Jun 13.'}, {'pmid': '17972366', 'type': 'BACKGROUND', 'citation': 'Soto RJ, Ghee AE, Nunez CA, Mayorga R, Tapia KA, Astete SG, Hughes JP, Buffardi AL, Holte SE, Holmes KK; Estudio Multicentrico Study Team. Sentinel surveillance of sexually transmitted infections/HIV and risk behaviors in vulnerable populations in 5 Central American countries. J Acquir Immune Defic Syndr. 2007 Sep 1;46(1):101-11.'}, {'pmid': '18687459', 'type': 'BACKGROUND', 'citation': 'Coates TJ, Richter L, Caceres C. Behavioural strategies to reduce HIV transmission: how to make them work better. Lancet. 2008 Aug 23;372(9639):669-84. doi: 10.1016/S0140-6736(08)60886-7. Epub 2008 Aug 5.'}, {'pmid': '21091279', 'type': 'BACKGROUND', 'citation': 'Grant RM, Lama JR, Anderson PL, McMahan V, Liu AY, Vargas L, Goicochea P, Casapia M, Guanira-Carranza JV, Ramirez-Cardich ME, Montoya-Herrera O, Fernandez T, Veloso VG, Buchbinder SP, Chariyalertsak S, Schechter M, Bekker LG, Mayer KH, Kallas EG, Amico KR, Mulligan K, Bushman LR, Hance RJ, Ganoza C, Defechereux P, Postle B, Wang F, McConnell JJ, Zheng JH, Lee J, Rooney JF, Jaffe HS, Martinez AI, Burns DN, Glidden DV; iPrEx Study Team. Preexposure chemoprophylaxis for HIV prevention in men who have sex with men. N Engl J Med. 2010 Dec 30;363(27):2587-99. doi: 10.1056/NEJMoa1011205. Epub 2010 Nov 23.'}, {'pmid': '22784038', 'type': 'BACKGROUND', 'citation': 'Thigpen MC, Kebaabetswe PM, Paxton LA, Smith DK, Rose CE, Segolodi TM, Henderson FL, Pathak SR, Soud FA, Chillag KL, Mutanhaurwa R, Chirwa LI, Kasonde M, Abebe D, Buliva E, Gvetadze RJ, Johnson S, Sukalac T, Thomas VT, Hart C, Johnson JA, Malotte CK, Hendrix CW, Brooks JT; TDF2 Study Group. Antiretroviral preexposure prophylaxis for heterosexual HIV transmission in Botswana. N Engl J Med. 2012 Aug 2;367(5):423-34. doi: 10.1056/NEJMoa1110711. Epub 2012 Jul 11.'}, {'pmid': '22784037', 'type': 'BACKGROUND', 'citation': 'Baeten JM, Donnell D, Ndase P, Mugo NR, Campbell JD, Wangisi J, Tappero JW, Bukusi EA, Cohen CR, Katabira E, Ronald A, Tumwesigye E, Were E, Fife KH, Kiarie J, Farquhar C, John-Stewart G, Kakia A, Odoyo J, Mucunguzi A, Nakku-Joloba E, Twesigye R, Ngure K, Apaka C, Tamooh H, Gabona F, Mujugira A, Panteleeff D, Thomas KK, Kidoguchi L, Krows M, Revall J, Morrison S, Haugen H, Emmanuel-Ogier M, Ondrejcek L, Coombs RW, Frenkel L, Hendrix C, Bumpus NN, Bangsberg D, Haberer JE, Stevens WS, Lingappa JR, Celum C; Partners PrEP Study Team. Antiretroviral prophylaxis for HIV prevention in heterosexual men and women. N Engl J Med. 2012 Aug 2;367(5):399-410. doi: 10.1056/NEJMoa1108524. Epub 2012 Jul 11.'}, {'pmid': '22784040', 'type': 'BACKGROUND', 'citation': "Van Damme L, Corneli A, Ahmed K, Agot K, Lombaard J, Kapiga S, Malahleha M, Owino F, Manongi R, Onyango J, Temu L, Monedi MC, Mak'Oketch P, Makanda M, Reblin I, Makatu SE, Saylor L, Kiernan H, Kirkendale S, Wong C, Grant R, Kashuba A, Nanda K, Mandala J, Fransen K, Deese J, Crucitti T, Mastro TD, Taylor D; FEM-PrEP Study Group. Preexposure prophylaxis for HIV infection among African women. N Engl J Med. 2012 Aug 2;367(5):411-22. doi: 10.1056/NEJMoa1202614. Epub 2012 Jul 11."}, {'pmid': '20809380', 'type': 'BACKGROUND', 'citation': 'Haberer JE, Kahane J, Kigozi I, Emenyonu N, Hunt P, Martin J, Bangsberg DR. Real-time adherence monitoring for HIV antiretroviral therapy. AIDS Behav. 2010 Dec;14(6):1340-6. doi: 10.1007/s10461-010-9799-4.'}, {'pmid': '22153566', 'type': 'BACKGROUND', 'citation': 'Kashuba AD, Patterson KB, Dumond JB, Cohen MS. Pre-exposure prophylaxis for HIV prevention: how to predict success. Lancet. 2012 Jun 30;379(9835):2409-2411. doi: 10.1016/S0140-6736(11)61852-7. Epub 2011 Dec 6. No abstract available.'}, {'pmid': '33191765', 'type': 'DERIVED', 'citation': 'Seneviratne HK, Tillotson J, Lade JM, Bekker LG, Li S, Pathak S, Justman J, Mgodi N, Swaminathan S, Sista N, Farrior J, Richardson P, Hendrix CW, Bumpus NN. Metabolism of Long-Acting Rilpivirine After Intramuscular Injection: HIV Prevention Trials Network Study 076 (HPTN 076). AIDS Res Hum Retroviruses. 2021 Mar;37(3):173-183. doi: 10.1089/AID.2020.0155. Epub 2021 Jan 13.'}, {'pmid': '31651098', 'type': 'DERIVED', 'citation': 'Tolley EE, Li S, Zangeneh SZ, Atujuna M, Musara P, Justman J, Pathak S, Bekker LG, Swaminathan S, Stanton J, Farrior J, Sista N. Acceptability of a long-acting injectable HIV prevention product among US and African women: findings from a phase 2 clinical Trial (HPTN 076). J Int AIDS Soc. 2019 Oct;22(10):e25408. doi: 10.1002/jia2.25408.'}]}, 'descriptionModule': {'briefSummary': 'This is a multi-site, double-blinded, two-arm, two:one, randomized, trial comparing the safety of an intramuscular (IM) injection of TMC278 LA to a placebo given once every eight weeks over a 40 week period among sexually active, HIV- uninfected women.', 'detailedDescription': 'This is a multi-site, double-blinded, two-arm, two:one randomized, placebo-controlled trial comparing the safety of TMC278 LA for 48 weeks after the initial 1M injection to a saline (0.9%NaCI) placebo IM injection among sexually active, HIV-uninfected women who are assessed by the clinic staff as being at "low risk" for HIV acquisition (in keeping with a safety trial). Approximately 132 women will be randomized to TMC278 LA and placebo in approximately a two:one ratio (88 and 44 in the TMC278 LA and placebo arm, respectively).\n\nApproximately 96 women will be enrolled in SSA and approximately 36 women will be enrolled in the US. In order to screen for initial safety and tolerability of the active product, a run-in period with oral rilpivirine will precede the injection of TMC278 LA. Participants randomized to the placebo arm will receive oral placebo capsules prior to injection of saline solution (0.9%NaCI). Participants will be observed while taking the study product by site staff on approximately six occasions during the first two weeks of the oral run-in at Week 0 (Enrollment), at Week 2 (Oral Run-in Safety Visit), and on four separate DOT visits between Weeks 0 and 2. Cervicovaginal and rectal fluid will be collected for PK studies at a single follow-up visit. A subset of approximately 24 women at US sites will have vaginal tissue collection for PK studies at a single follow-up visit (Tissue Subset).\n\nParticipants who present with Grade 2 or greater RELATED AEs during the oral-run in phase will not receive the injectable TMC278 LA. Participants who present with Grade 3 or 4 UNRELATED AEs will not proceed to the injectable phase unless approved by the Clinical Management Committee (CMC).\n\nArm 1: Participants randomized to the active arm will receive rilpivirine 25 mg capsules once daily for four weeks to be taken orally with a meal. Participants will then receive IM injections of TMC278 LA, 1200 mg dose, at eight week intervals (at Weeks 4, 12, 20, 28, 36 and 44). On each dosing occasion 1200 mg of TMC278 LA will be delivered in two, 2 mL injections, one in each gluteus maximus muscle. All participants will receive a total of six doses (12 IM injections).\n\nArm 2: Participants randomized to the placebo arm will receive placebo capsules once daily for four weeks to be taken orally with a meal. Participants will then receive IM injections of saline (0.9% NaCI) at eight week intervals (at Weeks 4, 12, 20, 28, 36 and 44). On each dosing occasion placebo will be delivered in two, 2 mL injections, one in each gluteus maximus muscle. All participants will receive a total of six doses (12 IM injections).\n\nStudy sites:\n\n* Bronx Prevention Center CRS, USA\n* New Jersey Medical School CRS, USA\n* Emavundleni CRS, Cape Town, South Africa\n* Spilhaus CRS, Harare, Zimbabwe'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria: Women who meet all of the following criteria will be eligible for inclusion in the study:\n\n* Women, 18- 45 years (inclusive) of age at Enrollment\n* Female at birth\n* Willing and able to provide informed consent to take part in the study\n* Willing and able to provide adequate locator information\n* Willing and able to provide acceptability and adherence assessments throughout the study\n* Understands and agrees to local reporting requirements for sexually transmitted infections (STis)\n* No evidence of an active STI, women who have an STI (Chlamydia trachomatis (CT), Neisseria gonorrhoeae (GC), or syphilis) identified at the Screening visit are ineligible\\*\n* Per participant report, no diagnosis of GC, CT, or syphilis in the last 6 months\n* Availability to return for all study visits and participate in all study-related procedures, barring unforeseen circumstances\n* Per participant report, using (or willing to use) an acceptable form of contraception (e.g., intrauterine device \\[IUD\\], hormonal contraception \\[DMPA\\], oral, injectable, transdermal patch, implants) from screening until one month after last study visit or surgical sterilization of the participant\n* Must agree to use condoms for the duration of the study\n* Must agree not to participate in other concurrent drug or vaccine trials\n* Normal laboratory values\\*\\*\n\n(HIV tests performed at Screening and Enrollment are non- reactive/negative (see Study Specific Procedures (SSP) Manual)\n\n* Hemoglobin (women) =:: 10.5 g/dL\n* Absolute neutrophil count1,000 cells/mm 3\n* Platelet count=:: 100,000/mm3\n* Calculated creatinine clearance =:: 70 mL!minute using the Cockcroft-Gault equation\n* Alanine aminotransferase (AST) and aspartate aminotransferase (ALT) \\< 2 times the upper limit of normal (ULN)\n* Total bilirubin \\< 2.5 ULN\n* Urine protein\\< 2+\n\n * Women who have an STI identified at the Screening visit (CT, GC, or syphilis) will be provided treatment but are ineligible. Women who report having CT, GC, or syphilis in the last six months are ineligible.\n\n * Specimens for Screening labs must be obtained within 28 days prior to study Enrollment.\n\n3.1.1 Inclusion Criteria for the Tissue Subset (US sites only) A subset of approximately 24 participants at US sites will participate in more intensive sampling of vaginal tissue during Week 36 (preferred) or Week 44.\n\nFor these participants, the following additional criteria need to be met:\n\n•Satisfactory Pap results in the 12 calendar months prior to biopsy consistent with Grade 0 according to the Female Genital Grading Table for Use in Microbicide Studies Addendum 1 to the DAIDS Table for Grading Adult and Pediatric Adverse Events, Version 1.0, December 2004 (Clarification dated August 2009), or satisfactory evaluation with no treatment required of Grade 1 or higher Pap result per American Society for Colposcopy and Cervical Pathology (ASCCP) guidelines in the 12 calendar months prior to biopsy is required, as indicated.\n\nIf there is no documentation of satisfactory Pap results, and if indicated, the participant should be offered to have the test performed by the site prior to enrollment in the Tissue Subset. If Pap testing is indicated and participants decline, they are not eligible for the Tissue Subset.\n\n* In addition to documentation of satisfactory Pap results, women must have normal laboratory results for coagulation tests to be eligible for the Tissue Subset. Abnormal coagulation test results may indicate an increased risk of bleeding.\n* Women have to be willing to abstain from vaginal intercourse and practices involving insertion of anything in the vagina (drug, douche, penis, or sex toy) for 3 days prior to vaginal biopsy and for 7 days post-biopsy, to minimize risk of HIV-1 infection and bleeding complications after the procedure.\n* Participants must not be pregnant at the time of vaginal sampling, based on pregnancy test results from previous visits and on the result of urine pregnancy test performed on the same day before the proposed vaginal sampling.\n* Women undergoing biopsy must have received all prior injections of study product, in accordance with the protocol, to be eligible for inclusion.\n\nExclusion Criteria: Women who meet any of the following criteria will be excluded from the study:\n\n* Experiencing early menopause using clinical criteria (amenorrhea greater than six months in absence of pregnancy) or a prior report of an abnormal Follicle Stimulating Hormone (FSH) test\n* PrEP or post-exposure prophylaxis (PEP) for HIV exposure within 90 days prior to Screening\n* Pregnant or last pregnancy outcome 90 days or less prior to Screening\n* Currently breastfeeding\n* Intends to become pregnant during the period of study participation\n* Experiencing uncontrolled depression or active suicidal ideation\n* History of recurrent urticaria\n* Any history of anaphylaxis or severe allergy resulting in angioedema\n* Any serious acute, chronic, or progressive disease (e.g. known history of neoplasm, cancer, insulin-dependent diabetes, cardiac disease, auto-immune disease), or with signs of cardiac disease, renal failure, or severe malnutrition\n* Any laboratory abnormalities that are Grade 2 or higher, according to the DAIDS Toxicology tables (please see Section 6.1 for a list of Screening laboratory tests)\n* Recreational injection drug use in the 52 weeks prior to screening\n* Participating or plans to participate in another research study involving study drugs, vaccines or medical devices\n* Participated in another research study involving study drugs, vaccines or medical devices within the four weeks prior to screening; may be longer than four weeks depending on half-life of study drug\n* Past participation in an HIV vaccine study\n* Has plans to relocate and cannot attend the visits at the clinic\n* Per participant report at Screening, current or anticipated ongoing use and/or unwillingness to abstain from contraindicated medications or supplements (listed in the SSP Manual)\n* Abnormal resting EKG at screening including:\n* Abnormal sinus rhythm (heart rate below 40 or above 100 beats per minute)\n* QTcF interval\\> 450 ms\n* QRS interval \\< 50 ms\n* QRS interval \\> 120 ms\n* PR interval\\> 210 ms\n* History of additional risk factors for Torsade de Pointes (TdP), such as heart failure, hypokalemia, hypomagnesia, family history of known long QT syndrome, or sudden death at young age (S 40 years) in a first-degree relative (i.e., biological parent, sibling, or offspring)\n* Currently active Tuberculosis (TB), or undergoing treatment for the same (by self-report)\n* Any signs or symptoms consistent with acute (pre-seroconversion) HIV infection, or self-reported concern about recent HIV infection\n* Any reactive or positive HIV test at Screening or Enrollment, even if the person is confirmed to be HIV-uninfected\n* Has any other condition that, in the opinion of the site loR or designee, would preclude informed consent, make study participation unsafe, interfere with adherence, complicate interpretation of study outcome data, or otherwise interfere with achieving study objectives (e.g., at increased risk of cardiovascular vents)\n\nWomen who do not meet eligibility criteria because of an abnormal EKG, risk factors for TdP, an STI (GC, CT, or syphilis) present at Screening or report of an STI (GC, CT, or syphilis) in the past 6 months, or a history of arrhythmia may not be re-screened.\n\nWomen who present at Screening with symptoms consistent with an acute HIV infection or who have a reactive HIV test may not be re-screened. Women who do not meet eligibility criteria for the study for other reason(s) may be re-screened at a future date at the discretion of the site loR.\n\n3.2.1 Exclusion Criteria for the Tissue Subset (US sites only)\n\nParticipants of the Tissue Subset must meet the above eligibility criteria to be enrolled in HPTN 076. Participants interested in participating in the Tissue Subset must meet additional inclusion and exclusion criteria. Women who meet any of the following criteria will be excluded from the Tissue Subset:\n\n* Unwillingness to abstain from the following medications for a period of 10 days before a biopsy procedure:\n* Aspirin\\*\n* Non-steroidal anti-inflammatory drugs (NSAIDS)\n\n \\*Daily use of low-dose aspirin (no more than 81 mg) is allowed at the discretion of the loR.\n* Unwillingness to abstain from the following medications for 3 days prior to vaginal biopsy and for 7 days post-biopsy: Heparin, including Lovenox®, Warfarin, Plavix® (clopidogrel bisulfate), and any other drugs that are associated with increased risk of bleeding following biopsy procedures at the discretion of the loR.\n* Carcinoma in situ of the cervix or invasive cervical cancer. Abnormalities of the vaginal mucosa or significant vaginal symptom(s), which in the opinion of the loR represent a contraindication to biopsy (including but not limited to presence of any unresolved injury, and infectious or inflammatory condition of the local mucosa).\n* Hysterectomy.'}, 'identificationModule': {'nctId': 'NCT02165202', 'acronym': 'TMC278LA', 'briefTitle': 'Phase II Safety and Acceptability of an Investigational Injectable Product, TMC278LA, for Pre-Exposure Prophylaxis', 'organization': {'class': 'OTHER', 'fullName': 'PATH'}, 'officialTitle': 'HPTN 076 - Phase II Safety and Acceptability of an Investigational Injectable Product, TMC278 LA, for Pre-Exposure Prophylaxis (PrEP)', 'orgStudyIdInfo': {'id': 'HPTN 076'}, 'secondaryIdInfos': [{'id': '1015131', 'type': 'OTHER_GRANT', 'domain': 'Bill & Melinda Gates Foundation (along with NIH for HPTN)'}, {'id': 'UM1AI068619', 'link': 'https://reporter.nih.gov/quickSearch/UM1AI068619', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Rilpivirine', 'description': 'Arm 1: Participants randomized to the active arm will receive rilpivirine 25 mg capsules once daily for four weeks to be taken orally with a meal. Participants will then receive IM injections of TMC278 LA, 1200 mg dose, at eight week intervals (at Weeks 4, 12, 20, 28, 36 and 44). On each dosing occasion 1200 mg of TMC278 LA will be delivered in two, 2 mL injections, one in each gluteus maximus muscle. All participants will receive a total of six doses (12 IM injections).', 'interventionNames': ['Drug: Rilpivirine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Arm 2: Participants randomized to the placebo arm will receive placebo capsules once daily for four weeks to be taken orally with a meal. Participants will then receive IM injections of saline (0.9% NaCI) at eight week intervals (at Weeks 4, 12, 20, 28, 36 and 44). On each dosing occasion placebo will be delivered in two, 2 mL injections, one in each gluteus maximus muscle. All participants will receive a total of six doses (12 IM injections).', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Rilpivirine', 'type': 'DRUG', 'description': "Rilpivirine (TMC278), a non-nucleoside reverse transcriptase inhibitor (NNRTI) is a substituted diaryl-pyrimidine (DAPY) derivative with potent antiviral activity against HIV. It is approved by the US FDA for once daily oral administration and is effective as part of treatment for ARV-na'ive HIV-infected patients as rilpivirine 25 mg capsules. It is also co-formulated with TDF and FTC for use as a once- daily single fixed-dose combination (Complera™).", 'armGroupLabels': ['Rilpivirine']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Participants randomized to the placebo arm will receive oral placebo capsules prior to injection of saline solution (0.9%NaCI). Participants will be observed while taking the study product by site staff on approximately six occasions during the first two weeks of the oral run-in at Week 0 (Enrollment), at Week 2 (Oral Run-in Safety Visit), and on four separate DOT visits between Weeks 0 and 2. Cervicovaginal and rectal fluid will be collected for PK studies at a single follow-up visit.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '07103', 'city': 'Newark', 'state': 'New Jersey', 'country': 'United States', 'facility': 'New Jersey Medical School Clinical Research Center', 'geoPoint': {'lat': 40.73566, 'lon': -74.17237}}, {'zip': '10451', 'city': 'The Bronx', 'state': 'New York', 'country': 'United States', 'facility': 'Bronx Prevention Center', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}, {'city': 'Cape Town', 'country': 'South Africa', 'facility': 'Emavundleni Clinical Research Site', 'geoPoint': {'lat': -33.92584, 'lon': 18.42322}}, {'city': 'Belgravia', 'state': 'Harare', 'country': 'Zimbabwe', 'facility': 'Spilhaus Clinical Research Site', 'geoPoint': {'lat': -17.80306, 'lon': 31.04972}}], 'overallOfficials': [{'name': 'Jessica Justman, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Bronx-Lebanon Hospital Center Clinical Research Site'}, {'name': 'Shobha Swaminathan, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'New Jersey Medical School Clinical Research Site'}, {'name': 'Zvavahera Michael Chirenje, MD, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Spilhaus Clinical Research Site'}, {'name': 'Linda-Gail Bekker, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'The Desmond Tutu HIV Centre'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'PATH', 'class': 'OTHER'}, 'collaborators': [{'name': 'Bill and Melinda Gates Foundation', 'class': 'OTHER'}, {'name': 'National Institute of Allergy and Infectious Diseases (NIAID)', 'class': 'NIH'}, {'name': 'National Institutes of Health (NIH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}