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Ignite Creation Date: 2025-12-25 @ 12:22 AM

Ignite Modification Date: 2026-03-01 @ 6:11 AM

Study NCT ID: NCT02990858

Status: TERMINATED

Last Update Posted: 2025-11-12

First Post: 2016-11-17

Is Gene Therapy: True

Has Adverse Events: True

Brief Title: An Extension Protocol for Subjects Who Successfully Completed PRO140_CD02 or PRO140_CD02_Open Label Study

Sponsor:

Organization:

Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

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': 'C420063', 'term': 'leronlimab'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jmeidling@cytodyn.com', 'phone': '36009808524', 'title': 'Vice President, Clinical Operations', 'organization': 'CytoDyn'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'FDA required the sponsor to halt enrollment in the trial and transition participants to available therapies for the treatment of their disease. The trial was subsequently terminated once participants were transitioned.'}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were reported from the time of the first treatment extension visit and continue up until the final study visit, up to 56 months.', 'description': 'Adverse events were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed were clinically significant to the research subject and that occurred after initiation of the first study treatment was reported as an adverse event.', 'eventGroups': [{'id': 'EG000', 'title': 'PRO 140 350 mg', 'description': 'Eligible subjects received 350 mg PRO 140 (leronlimab) administered weekly as subcutaneous injections along with Optimized Background Therapy (OBT) until virologic failure or another reason for discontinuation.', 'otherNumAtRisk': 29, 'deathsNumAtRisk': 29, 'otherNumAffected': 27, 'seriousNumAtRisk': 29, 'deathsNumAffected': 3, 'seriousNumAffected': 11}, {'id': 'EG001', 'title': 'PRO 140 700 mg', 'description': 'Eligible subjects received 700 mg PRO 140 (leronlimab) administered weekly as subcutaneous injections along with Optimized Background Therapy (OBT) until virologic failure or another reason for discontinuation.', 'otherNumAtRisk': 14, 'deathsNumAtRisk': 14, 'otherNumAffected': 13, 'seriousNumAtRisk': 14, 'deathsNumAffected': 1, 'seriousNumAffected': 4}], 'otherEvents': [{'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 10, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Injection site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 6, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Injection site haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 10, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 8, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 6, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 3, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 7, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Ecchymosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 6, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 7, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Abdominal rebound tenderness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Arthropod bite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Blood HIV RNA increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 6, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Chronic kidney disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Covid-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Gastrointestinal viral infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Herpes zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Hydrocele', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Lip Injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Nasal Congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Oral candidiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Orchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Red blood cells urine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Tooth infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Uveitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Wound infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Sciatica', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Anal fissure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Anal dysplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Scapula pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Hearing loss', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Olecranon bursitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}], 'seriousEvents': [{'term': 'Coronary artery occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Aplastic anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Haematochezia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Multiple organ dysfunction syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Epstein-Barr virus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Septic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Mycobacterium avium complex infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Pyelonephritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Medical device site joint infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Staphylococcal bacteraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Abscess limb', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Head Injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Myelodysplastic syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Arterial thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mean Change in Viral Load (HIV-1 RNA Levels) at the Conclusion of Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PRO 140', 'description': 'Eligible subjects received 350 mg or 700 mg PRO 140 (leronlimab) administered weekly as subcutaneous injections along with Optimized Background Therapy (OBT) until virologic failure or another reason for discontinuation.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.13', 'spread': '1.11', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From TE1 (first treatment administration) to once every four weeks until last treatment visit (up to 56 months).', 'description': 'The change from baseline in HIV-1 RNA levels (log 10 copies/mL) was summarized at least once every four weeks during the treatment extension phase. The time-weighted mean of change of the post baseline values was calculated. The time-weighted mean was adjusted AUC (area under the curve) by time.', 'unitOfMeasure': 'log10 copies/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population is defined as all subjects who enrolled in the study and received at least one dose of PRO 140. Subjects who had undefined change from baseline due to missing data were excluded from the analysis population.'}, {'type': 'SECONDARY', 'title': 'Mean Change in CD4 Cell Count at the Conclusion of Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PRO 140', 'description': 'Eligible subjects received 350 mg or 700 mg PRO 140 (leronlimab) administered weekly as subcutaneous injections along with Optimized Background Therapy (OBT) until virologic failure or another reason for discontinuation.'}], 'classes': [{'categories': [{'measurements': [{'value': '46', 'spread': '122', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From first treatment administration to each weekly visit until the last treatment visit (up to 56 months)', 'description': 'The change from baseline in CD4 cell count was summarized for each visit during the treatment phase. The time-weighted mean of change of the post baseline values was calculated. The time-weighted mean was adjusted AUC (area under the curve) by time.', 'unitOfMeasure': 'cells/uL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population is defined as all subjects who enrolled in the study and received at least one dose of PRO 140. Subjects who had undefined change from baseline due to missing data were excluded from the analysis population.'}, {'type': 'SECONDARY', 'title': 'Proportion of Participants Experiencing Emergence of Dual/Mixed (D/M)- and CXCR4-tropic Virus in Patients Who Had Exclusive CCR5-tropic Virus at Study Entry.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PRO 140', 'description': 'Eligible subjects received 350 mg or 700 mg PRO 140 (leronlimab) administered weekly as subcutaneous injections along with Optimized Background Therapy (OBT) until virologic failure or another reason for discontinuation.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.093', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From TE1 (first treatment administration) to last treatment visit, up to 56 months.', 'description': 'All patients have exclusive C-C chemokine receptor type 5 (CCR5)-tropic virus at study entry. The proportion of patients with any tropism result of dual/mixed was summarized.', 'unitOfMeasure': 'proportion of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population is defined as all subjects who enrolled in the extension portion of the study and received at least one dose of PRO140. Participants who had no dual/mixed tropism data collected or had undefined change from baseline due to missing data were excluded from the analysis.'}, {'type': 'SECONDARY', 'title': 'Tolerability of Repeated Subcutaneous Administration of PRO 140 as Assessed by Investigator Evaluation of Injection Site Reactions (ISR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PRO 140', 'description': 'Eligible subjects received 350 mg or 700 mg PRO 140 (leronlimab) administered weekly as subcutaneous injections along with Optimized Background Therapy (OBT) until virologic failure or another reason for discontinuation.'}], 'classes': [{'title': 'Participants with no ISR symptoms', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}]}]}, {'title': 'Participants with Grade 1 ISR', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}]}]}, {'title': 'Participants with Grade 2 or higher ISR', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From TE1 (first treatment administration) weekly until last treatment visit (up to 56 months).', 'description': 'At each visit during the treatment extension phase, an injection site reaction assessment was completed for the current and previous injection sites. To assess severity, subcutaneous (SC) injection related events were recorded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table).\n\nGrade 1 indicates a mild event Grade 2 indicates a moderate event Grade 3 indicates a severe event Grade 4 indicates a potentially life-threatening event Participants who had no symptoms of injection site reactions, "0" was assigned.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients who received at least one dose of PRO 140 (leronlimab) were included in the baseline analysis population. Subjects who had undefined value due to missing data were excluded from the analysis population.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Treatment-related Adverse Events Resulting in Study Drug Discontinuation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PRO 140', 'description': 'Eligible subjects received either 350 mg or 700 mg PRO 140 (leronlimab) administered weekly as subcutaneous injections along with Optimized Background Therapy (OBT) until virologic failure or another reason for discontinuation.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From TE1 (first treatment administration) to last treatment visit, up to 56 months.', 'description': 'Treatment-related adverse events are defined as events with an onset on or after the first treatment (TE1).', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients who received at least one dose of PRO 140 (leronlimab) were included in the baseline analysis population.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Grade 3 or 4 Adverse Events as Defined by the DAIDS Adverse Event Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PRO 140', 'description': 'Eligible subjects received either 350 mg or 700 mg PRO 140 (leronlimab) administered weekly as subcutaneous injections along with Optimized Background Therapy (OBT) until virologic failure or another reason for discontinuation.'}], 'classes': [{'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From TE1 (first treatment administration) to last treatment visit, up to 56 months.', 'description': 'The Division of AIDS (DAIDS) grading table provides an adverse event severity grading scale ranging from grades 1 to 5 with descriptions for each adverse event based on the following general guidelines:\n\n* Grade 1 indicates a mild event\n* Grade 2 indicates a moderate event\n* Grade 3 indicates a severe event\n* Grade 4 indicates a potentially life-threatening event\n* Grade 5 indicates death (Note: This grade is not specifically listed on each page of the grading table).', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients who received at least one dose of PRO 140 (leronlimab) were included in the baseline analysis population.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With at Least One Treatment-related Serious Adverse Event.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PRO 140', 'description': 'Eligible subjects received either 350 mg or 700 mg PRO 140 (leronlimab) administered weekly as subcutaneous injections along with Optimized Background Therapy (OBT) until virologic failure or another reason for discontinuation.'}], 'classes': [{'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From TE1 (first treatment administration) to last treatment visit, up to 56 months.', 'description': 'Treatment-related (as defined by the investigator) serious adverse events are defined as serious events with an onset on or after the first treatment.\n\nA serious adverse event is defined as any adverse event that:\n\n* Results in death\n* Is life threatening (the subject is at immediate risk of dying from the AE)\n* Requires subject hospitalization or prolongs existing hospitalization\n* Results in persistent or significant disability/incapacity\n* Is a congenital anomaly/birth defect Important medical events that may not result in death, be life-threatening, or require hospitalization may be considered a serious adverse event when, based upon appropriate medical judgment, they may jeopardize the subject and may require medical or surgical intervention to prevent one of the outcomes listed in this definition.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients who received at least one dose of PRO 140 (leronlimab) were included in the baseline analysis population.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'PRO 140', 'description': 'Eligible subjects received 350 mg or 700 mg PRO 140 (leronlimab) administered weekly as subcutaneous injections along with Optimized Background Therapy (OBT) until virologic failure or another reason for discontinuation.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '43'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '23'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}]}]}], 'recruitmentDetails': 'This trial was conducted in 43 participants in the United States.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'PRO 140', 'description': 'Eligible subjects received 350 mg or 700 mg PRO 140 (leronlimab) administered weekly as subcutaneous injections along with Optimized Background Therapy (OBT) until virologic failure or another reason for discontinuation.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '43', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '53.07', 'spread': '7.31', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '33', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '34', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '18', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '23', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '43', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'All patients who received at least one dose of PRO 140 (leronlimab) were included in the baseline analysis population.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-04-02', 'size': 3802848, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-07-16T08:05', 'hasProtocol': True}, {'date': '2020-05-19', 'size': 1467029, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-07-16T13:03', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 43}}, 'statusModule': {'whyStopped': 'FDA required the sponsor to halt enrollment in the trial and transition participants to available therapies for the treatment of their disease. The trial was subsequently terminated once participants were transitioned.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2016-11-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2022-07-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-10-28', 'studyFirstSubmitDate': '2016-11-17', 'resultsFirstSubmitDate': '2025-08-05', 'studyFirstSubmitQcDate': '2016-12-08', 'lastUpdatePostDateStruct': {'date': '2025-11-12', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-10-28', 'studyFirstPostDateStruct': {'date': '2016-12-13', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2025-11-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2022-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Change in Viral Load (HIV-1 RNA Levels) at the Conclusion of Treatment Period', 'timeFrame': 'From TE1 (first treatment administration) to once every four weeks until last treatment visit (up to 56 months).', 'description': 'The change from baseline in HIV-1 RNA levels (log 10 copies/mL) was summarized at least once every four weeks during the treatment extension phase. The time-weighted mean of change of the post baseline values was calculated. The time-weighted mean was adjusted AUC (area under the curve) by time.'}], 'secondaryOutcomes': [{'measure': 'Mean Change in CD4 Cell Count at the Conclusion of Treatment Period', 'timeFrame': 'From first treatment administration to each weekly visit until the last treatment visit (up to 56 months)', 'description': 'The change from baseline in CD4 cell count was summarized for each visit during the treatment phase. The time-weighted mean of change of the post baseline values was calculated. The time-weighted mean was adjusted AUC (area under the curve) by time.'}, {'measure': 'Proportion of Participants Experiencing Emergence of Dual/Mixed (D/M)- and CXCR4-tropic Virus in Patients Who Had Exclusive CCR5-tropic Virus at Study Entry.', 'timeFrame': 'From TE1 (first treatment administration) to last treatment visit, up to 56 months.', 'description': 'All patients have exclusive C-C chemokine receptor type 5 (CCR5)-tropic virus at study entry. The proportion of patients with any tropism result of dual/mixed was summarized.'}, {'measure': 'Tolerability of Repeated Subcutaneous Administration of PRO 140 as Assessed by Investigator Evaluation of Injection Site Reactions (ISR)', 'timeFrame': 'From TE1 (first treatment administration) weekly until last treatment visit (up to 56 months).', 'description': 'At each visit during the treatment extension phase, an injection site reaction assessment was completed for the current and previous injection sites. To assess severity, subcutaneous (SC) injection related events were recorded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table).\n\nGrade 1 indicates a mild event Grade 2 indicates a moderate event Grade 3 indicates a severe event Grade 4 indicates a potentially life-threatening event Participants who had no symptoms of injection site reactions, "0" was assigned.'}, {'measure': 'Number of Participants With Treatment-related Adverse Events Resulting in Study Drug Discontinuation', 'timeFrame': 'From TE1 (first treatment administration) to last treatment visit, up to 56 months.', 'description': 'Treatment-related adverse events are defined as events with an onset on or after the first treatment (TE1).'}, {'measure': 'Number of Participants With Grade 3 or 4 Adverse Events as Defined by the DAIDS Adverse Event Scale', 'timeFrame': 'From TE1 (first treatment administration) to last treatment visit, up to 56 months.', 'description': 'The Division of AIDS (DAIDS) grading table provides an adverse event severity grading scale ranging from grades 1 to 5 with descriptions for each adverse event based on the following general guidelines:\n\n* Grade 1 indicates a mild event\n* Grade 2 indicates a moderate event\n* Grade 3 indicates a severe event\n* Grade 4 indicates a potentially life-threatening event\n* Grade 5 indicates death (Note: This grade is not specifically listed on each page of the grading table).'}, {'measure': 'Number of Participants With at Least One Treatment-related Serious Adverse Event.', 'timeFrame': 'From TE1 (first treatment administration) to last treatment visit, up to 56 months.', 'description': 'Treatment-related (as defined by the investigator) serious adverse events are defined as serious events with an onset on or after the first treatment.\n\nA serious adverse event is defined as any adverse event that:\n\n* Results in death\n* Is life threatening (the subject is at immediate risk of dying from the AE)\n* Requires subject hospitalization or prolongs existing hospitalization\n* Results in persistent or significant disability/incapacity\n* Is a congenital anomaly/birth defect Important medical events that may not result in death, be life-threatening, or require hospitalization may be considered a serious adverse event when, based upon appropriate medical judgment, they may jeopardize the subject and may require medical or surgical intervention to prevent one of the outcomes listed in this definition.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['HIV', 'Human Immunodeficiency Virus'], 'conditions': ['Human Immunodeficiency Virus (HIV)']}, 'descriptionModule': {'briefSummary': 'PRO 140\\_CD02 Extension study seeks to evaluate the long-term efficacy, safety and tolerability of PRO 140 weekly injection in combination with Optimized Background Therapy (OBT) in patients infected with Human Immunodeficiency virus (HIV-1).', 'detailedDescription': 'This is an extension study, to provide continued access to PRO 140 to subjects who complete participation in PRO140\\_CD02 and continue to receive clinical benefit and would require PRO 140 to form a viable regimen, in the opinion of the treating physician. The patient population for this trial are treatment-experienced HIV infected patients with C-C Chemokine Receptor Type 5 (CCR5)-tropic virus who demonstrate evidence of HIV-1 suppression after successfully completed 24 weeks of treatment in the PRO140\\_CD02 or CD02\\_OpenLabel study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria: Potential subjects are required to meet all of the following criteria for enrollment into the study.\n\n1. Subjects who have completed 24 weeks of treatment in PRO 140\\_CD 02 or CD02\\_OpenLabel study, and Investigator believes subject requires continued access to PRO 140 in order to continue deriving clinical benefit and maintain HIV-1 viral suppression.\n2. HIV-1 RNA ≤ 50 copies/ml at T23 Visit in PRO140\\_CD02 study\n3. Both male and female patients and their partners of childbearing potential must agree to use 2 medically accepted methods of contraception (e.g., barrier contraceptives \\[male condom, female condom, or diaphragm with a spermicidal gel\\], hormonal contraceptives \\[implants, injectables, combination oral contraceptives, transdermal patches, or contraceptive rings\\], and intrauterine devices) during the course of the study (excluding women who are not of childbearing potential and men who have been sterilized).\n\n Females of childbearing potential must have a negative urine pregnancy test prior to receiving the first dose of study drug.\n4. Willing and able to participate in all aspects of the study, including use of subcutaneous (SC) medication, completion of subjective evaluations, attendance at scheduled clinic visits, and compliance with all protocol requirements as evidenced by providing written informed consent.\n\nExclusion Criteria: Potential subjects meeting any of the following criteria will be excluded from enrollment.\n\n1. Not currently enrolled in PRO 140\\_CD 02 or CD02\\_OpenLabel study\n2. Any active infection or malignancy requiring acute therapy (with the exception of local cutaneous Kaposi's sarcoma)\n3. Females who are pregnant, lactating, or breastfeeding, or who plan to become pregnant during the study\n4. Any other clinical condition that, in the Investigator's judgment, would potentially compromise study compliance or the ability to evaluate safety measures"}, 'identificationModule': {'nctId': 'NCT02990858', 'briefTitle': 'An Extension Protocol for Subjects Who Successfully Completed PRO140_CD02 or PRO140_CD02_Open Label Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'CytoDyn, Inc.'}, 'officialTitle': 'An Extension Protocol for Subjects Who Successfully Completed PRO140_CD02 or PRO140_CD02_Open Label Study', 'orgStudyIdInfo': {'id': 'PRO 140 _CD02 Extension'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Leronlimab (PRO 140)', 'description': 'The treatment extension phase consists of weekly treatment injection of PRO 140 in addition to Optimized Background Therapy.', 'interventionNames': ['Drug: PRO 140']}], 'interventions': [{'name': 'PRO 140', 'type': 'DRUG', 'otherNames': ['Leronlimab'], 'description': 'PRO 140 is a humanized IgG4, monoclonal antibody (mAb) to the C-C chemokine receptor type 5 (CCR5). Participants received 350 or 700 mg weekly injections of PRO 140.', 'armGroupLabels': ['Leronlimab (PRO 140)']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Jacob Lalezari, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CytoDyn, Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CytoDyn, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}