Ignite Creation Date:
2025-12-25 @ 12:10 AM
Ignite Modification Date:
2025-12-25 @ 10:10 PM
Study NCT ID:
NCT01650558
Status:
COMPLETED
Last Update Posted:
2022-07-28
First Post:
2012-07-06
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Daily Trimethoprim-sulfamethoxazole or Weekly Chloroquine Among Adults on ART in Malawi
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008288', 'term': 'Malaria'}], 'ancestors': [{'id': 'D011528', 'term': 'Protozoan Infections'}, {'id': 'D010272', 'term': 'Parasitic Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D000096724', 'term': 'Mosquito-Borne Diseases'}, {'id': 'D000079426', 'term': 'Vector Borne Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015662', 'term': 'Trimethoprim, Sulfamethoxazole Drug Combination'}, {'id': 'D002738', 'term': 'Chloroquine'}], 'ancestors': [{'id': 'D013420', 'term': 'Sulfamethoxazole'}, {'id': 'D000096926', 'term': 'Benzenesulfonamides'}, {'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013424', 'term': 'Sulfanilamides'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D014295', 'term': 'Trimethoprim'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D004338', 'term': 'Drug Combinations'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D000634', 'term': 'Aminoquinolines'}, {'id': 'D011804', 'term': 'Quinolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'mlaufer@som.umaryland.edu', 'phone': '410-706-5333', 'title': 'Miriam K. Laufer, M.D., M.P.H.', 'organization': 'University of Maryland School of Medicine'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '2 to 5.5 years', 'eventGroups': [{'id': 'EG000', 'title': 'Standard of Care Trimethoprim Sulfamethoxazo (TS) Prophylaxis', 'description': 'Participants will continue standard of care daily TS prophylaxis (two tablets each of 80 mg trimethoprim and 400 mg sulfamethoxazole or one tablet each of 160 mg trimethoprim and 800 mg sulfamethoxazole).', 'otherNumAtRisk': 500, 'deathsNumAtRisk': 500, 'otherNumAffected': 488, 'seriousNumAtRisk': 500, 'deathsNumAffected': 10, 'seriousNumAffected': 72}, {'id': 'EG001', 'title': 'Chloroquine (CQ) Prophylaxis', 'description': 'Participants will discontinue standard of care trimethoprim sulfamethoxazol prophylaxis and start weekly CQ prophylaxis at 300 mg.', 'otherNumAtRisk': 500, 'deathsNumAtRisk': 500, 'otherNumAffected': 483, 'seriousNumAtRisk': 500, 'deathsNumAffected': 6, 'seriousNumAffected': 99}, {'id': 'EG002', 'title': 'Discontinuation of Standard of Care (Control Arm)', 'description': 'Participants will discontinue standard of care trimethoprim sulfamethoxazol prophylaxis and receive no prophylaxis.', 'otherNumAtRisk': 499, 'deathsNumAtRisk': 499, 'otherNumAffected': 488, 'seriousNumAtRisk': 499, 'deathsNumAffected': 8, 'seriousNumAffected': 116}], 'otherEvents': [{'term': 'Infections', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numAffected': 414}, {'groupId': 'EG001', 'numAtRisk': 500, 'numAffected': 428}, {'groupId': 'EG002', 'numAtRisk': 499, 'numAffected': 443}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'General', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numAffected': 304}, {'groupId': 'EG001', 'numAtRisk': 500, 'numAffected': 267}, {'groupId': 'EG002', 'numAtRisk': 499, 'numAffected': 312}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Investigations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numAffected': 298}, {'groupId': 'EG001', 'numAtRisk': 500, 'numAffected': 307}, {'groupId': 'EG002', 'numAtRisk': 499, 'numAffected': 278}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Gastrointestinal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numAffected': 248}, {'groupId': 'EG001', 'numAtRisk': 500, 'numAffected': 243}, {'groupId': 'EG002', 'numAtRisk': 499, 'numAffected': 291}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Musculoskeletal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numAffected': 256}, {'groupId': 'EG001', 'numAtRisk': 500, 'numAffected': 223}, {'groupId': 'EG002', 'numAtRisk': 499, 'numAffected': 264}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Blood', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numAffected': 240}, {'groupId': 'EG001', 'numAtRisk': 500, 'numAffected': 222}, {'groupId': 'EG002', 'numAtRisk': 499, 'numAffected': 205}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Nervous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numAffected': 217}, {'groupId': 'EG001', 'numAtRisk': 500, 'numAffected': 209}, {'groupId': 'EG002', 'numAtRisk': 499, 'numAffected': 224}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numAffected': 140}, {'groupId': 'EG001', 'numAtRisk': 500, 'numAffected': 133}, {'groupId': 'EG002', 'numAtRisk': 499, 'numAffected': 138}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numAffected': 122}, {'groupId': 'EG001', 'numAtRisk': 500, 'numAffected': 130}, {'groupId': 'EG002', 'numAtRisk': 499, 'numAffected': 126}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Reproductive system', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numAffected': 85}, {'groupId': 'EG001', 'numAtRisk': 500, 'numAffected': 94}, {'groupId': 'EG002', 'numAtRisk': 499, 'numAffected': 93}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Injuries', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numAffected': 85}, {'groupId': 'EG001', 'numAtRisk': 500, 'numAffected': 82}, {'groupId': 'EG002', 'numAtRisk': 499, 'numAffected': 79}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Respiratory', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numAffected': 59}, {'groupId': 'EG001', 'numAtRisk': 500, 'numAffected': 65}, {'groupId': 'EG002', 'numAtRisk': 499, 'numAffected': 59}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Vascular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 500, 'numAffected': 29}, {'groupId': 'EG002', 'numAtRisk': 499, 'numAffected': 31}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pregnancy, puerperium and perinatal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 500, 'numAffected': 27}, {'groupId': 'EG002', 'numAtRisk': 499, 'numAffected': 29}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Metabolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 500, 'numAffected': 26}, {'groupId': 'EG002', 'numAtRisk': 499, 'numAffected': 22}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Ear and labyrinth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 500, 'numAffected': 24}, {'groupId': 'EG002', 'numAtRisk': 499, 'numAffected': 18}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Neoplasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 500, 'numAffected': 23}, {'groupId': 'EG002', 'numAtRisk': 499, 'numAffected': 16}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cardiac', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 500, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 499, 'numAffected': 19}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Renal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 500, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 499, 'numAffected': 19}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Psychiatric', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 500, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 499, 'numAffected': 5}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Surgical and medical', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 500, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 499, 'numAffected': 7}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hepatobiliary', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 500, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 499, 'numAffected': 3}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Endocrine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 500, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 499, 'numAffected': 2}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Congenital, familial and genetic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 500, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 499, 'numAffected': 1}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'seriousEvents': [{'term': 'Infections', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numEvents': 24, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 500, 'numEvents': 36, 'numAffected': 32}, {'groupId': 'EG002', 'numAtRisk': 499, 'numEvents': 48, 'numAffected': 40}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pregnancy, puerperium and perinatal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numEvents': 21, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 500, 'numEvents': 29, 'numAffected': 26}, {'groupId': 'EG002', 'numAtRisk': 499, 'numEvents': 32, 'numAffected': 29}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Nervous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 500, 'numEvents': 20, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 499, 'numEvents': 8, 'numAffected': 7}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Injuries', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 500, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 499, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Gastrointestinal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 500, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 499, 'numEvents': 9, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Neoplasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 500, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 499, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Surgical and medical', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 500, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 499, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'General', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 500, 'numEvents': 6, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 499, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Reproductive system', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 500, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 499, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Respiratory', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 500, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 499, 'numEvents': 5, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Blood', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 500, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 499, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Psychiatric', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 500, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 499, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 500, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 499, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Vascular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 500, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 499, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Metabolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 500, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 499, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cardiac', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 500, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 499, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Endocrine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 500, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 499, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hepatobiliary', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 500, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 499, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Musculoskeletal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 500, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 499, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Renal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 500, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 500, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 499, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Severe Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '500', 'groupId': 'OG000'}, {'value': '500', 'groupId': 'OG001'}, {'value': '499', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard of Care Trimethoprim Sulfamethoxazol (TS) Prophylaxis', 'description': 'Participants will continue standard of care daily TS prophylaxis (two tablets each of 80 mg trimethoprim and 400 mg sulfamethoxazole or one tablet each of 160 mg trimethoprim and 800 mg sulfamethoxazole).'}, {'id': 'OG001', 'title': 'Chloroquine (CQ) Prophylaxis', 'description': 'Participants will discontinue standard of care trimethoprim sulfamethoxazol prophylaxis and start weekly CQ prophylaxis at 300 mg.'}, {'id': 'OG002', 'title': 'Discontinuation of Standard of Care (Control Arm)', 'description': 'Participants will discontinue standard of care trimethoprim sulfamethoxazol prophylaxis and receive no prophylaxis.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.3', 'groupId': 'OG000'}, {'value': '4.2', 'groupId': 'OG001'}, {'value': '4.2', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<=0.05', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.27', 'ciLowerLimit': '0.89', 'ciUpperLimit': '1.82', 'pValueComment': 'P-Value is not adjusted for multiple comparisons.', 'statisticalMethod': 'Poisson', 'nonInferiorityType': 'NON_INFERIORITY', 'statisticalComment': "Rate ratio confidence intervals and p-values were adjusted for overdispersion using the Pearson's chi-square scale.", 'nonInferiorityComment': 'Will assess performance of each experimental group relative to TS with a noninferiority margin for 1-HR of 0.35 to test the null (1-HR ≥ 0.35) and alternative (1-HR \\< 0.35) hypotheses. Each experimental group will be declared noninferior to TS if the upper bound of the 95% confidence interval of 1-HR is below 0.35. For ease of interpretation, the HRs have been recast with TS as the reference group, such that HRs greater than 1 indicate an increase in the experimental hazard rate relative to TS.'}, {'pValue': '<=0.05', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.28', 'ciLowerLimit': '0.89', 'ciUpperLimit': '1.83', 'pValueComment': 'P-Value is not adjusted for multiple comparisons.', 'statisticalMethod': 'Poisson', 'nonInferiorityType': 'NON_INFERIORITY', 'statisticalComment': "Rate ratio confidence intervals and p-values were adjusted for overdispersion using the Pearson's chi-square scale.", 'nonInferiorityComment': 'Will assess performance of each experimental group relative to TS with a noninferiority margin for 1-HR of 0.35 to test the null (1-HR ≥ 0.35) and alternative (1-HR \\< 0.35) hypotheses. Each experimental group will be declared noninferior to TS if the upper bound of the 95% confidence interval of 1-HR is below 0.35. For ease of interpretation, the HRs have been recast with TS as the reference group, such that HRs greater than 1 indicate an increase in the experimental hazard rate relative to TS.'}], 'paramType': 'NUMBER', 'timeFrame': '22-66 months', 'description': 'Incidence of severe events (composite of death and WHO stage 3 and 4 illness)', 'unitOfMeasure': 'Events per 100 participant-years', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With at Least One Detectable HIV Viral Load', 'denoms': [{'units': 'Participants', 'counts': [{'value': '500', 'groupId': 'OG000'}, {'value': '500', 'groupId': 'OG001'}, {'value': '499', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard of Care Trimethoprim Sulfamethoxazol (TS) Prophylaxis', 'description': 'Participants will continue standard of care daily TS prophylaxis (two tablets each of 80 mg trimethoprim and 400 mg sulfamethoxazole or one tablet each of 160 mg trimethoprim and 800 mg sulfamethoxazole).'}, {'id': 'OG001', 'title': 'Chloroquine (CQ) Prophylaxis', 'description': 'Participants will discontinue standard of care trimethoprim sulfamethoxazol prophylaxis and start weekly CQ prophylaxis at 300 mg.'}, {'id': 'OG002', 'title': 'Discontinuation of Standard of Care (Control Arm)', 'description': 'Participants will discontinue standard of care trimethoprim sulfamethoxazol prophylaxis and receive no prophylaxis.'}], 'classes': [{'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<=0.05', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.38', 'ciLowerLimit': '0.83', 'ciUpperLimit': '2.30', 'pValueComment': 'No adjustment for multiple comparisons was made.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Will assess performance of each experimental group relative to TS with a noninferiority margin for 1-HR of 0.35 to test the null (1-HR ≥ 0.35) and alternative (1-HR \\< 0.35) hypotheses. Each experimental group will be declared noninferior to TS if the upper bound of the 95% confidence interval of 1-HR is below 0.35. For ease of interpretation, the HRs have been recast with TS as the reference group, such that HRs greater than 1 indicate an increase in the experimental hazard rate relative to TS.'}, {'pValue': '<=0.05', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.51', 'ciLowerLimit': '0.91', 'ciUpperLimit': '2.49', 'pValueComment': 'No adjustment for multiple comparisons was made.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Will assess performance of each experimental group relative to TS with a noninferiority margin for 1-HR of 0.35 to test the null (1-HR ≥ 0.35) and alternative (1-HR \\< 0.35) hypotheses. Each experimental group will be declared noninferior to TS if the upper bound of the 95% confidence interval of 1-HR is below 0.35. For ease of interpretation, the HRs have been recast with TS as the reference group, such that HRs greater than 1 indicate an increase in the experimental hazard rate relative to TS.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Throughout study participation, measured every six months (2-5.5 years).', 'description': 'Number of participants who ever have a detectable viral load (\\>400 copies/ml).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'CD4 Cell Count', 'denoms': [{'units': 'Participants', 'counts': [{'value': '500', 'groupId': 'OG000'}, {'value': '500', 'groupId': 'OG001'}, {'value': '499', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard of Care Trimethoprim Sulfamethoxazol (TS) Prophylaxis', 'description': 'Participants will continue standard of care daily TS prophylaxis (two tablets each of 80 mg trimethoprim and 400 mg sulfamethoxazole or one tablet each of 160 mg trimethoprim and 800 mg sulfamethoxazole).'}, {'id': 'OG001', 'title': 'Chloroquine (CQ) Prophylaxis', 'description': 'Participants will discontinue standard of care trimethoprim sulfamethoxazol prophylaxis and start weekly CQ prophylaxis at 300 mg.'}, {'id': 'OG002', 'title': 'Discontinuation of Standard of Care (Control Arm)', 'description': 'Participants will discontinue standard of care trimethoprim sulfamethoxazol prophylaxis and receive no prophylaxis.'}], 'classes': [{'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<=0.05', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.13', 'ciLowerLimit': '0.66', 'ciUpperLimit': '1.93', 'pValueComment': 'No adjustments for multiple comparisons were made.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Will assess performance of each experimental group relative to TS with a noninferiority margin for 1-HR of 0.35 to test the null (1-HR ≥ 0.35) and alternative (1-HR \\< 0.35) hypotheses. Each experimental group will be declared noninferior to TS if the upper bound of the 95% confidence interval of 1-HR is below 0.35. For ease of interpretation, the HRs have been recast with TS as the reference group, such that HRs greater than 1 indicate an increase in the experimental hazard rate relative to TS.'}, {'pValue': '<=0.05', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.96', 'ciLowerLimit': '0.55', 'ciUpperLimit': '1.68', 'pValueComment': 'No adjustments for multiple comparisons were made.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Will assess performance of each experimental group relative to TS with a noninferiority margin for 1-HR of 0.35 to test the null (1-HR ≥ 0.35) and alternative (1-HR \\< 0.35) hypotheses. Each experimental group will be declared noninferior to TS if the upper bound of the 95% confidence interval of 1-HR is below 0.35. For ease of interpretation, the HRs have been recast with TS as the reference group, such that HRs greater than 1 indicate an increase in the experimental hazard rate relative to TS.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Every 6 months for 22-66 months', 'description': 'Number of Participants with at Least One CD4 Count \\<200', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'WHO HIV Stage 2, 3, 4 Illness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '500', 'groupId': 'OG000'}, {'value': '500', 'groupId': 'OG001'}, {'value': '499', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard of Care Trimethoprim Sulfamethoxazol (TS) Prophylaxis', 'description': 'Participants will continue standard of care daily TS prophylaxis (two tablets each of 80 mg trimethoprim and 400 mg sulfamethoxazole or one tablet each of 160 mg trimethoprim and 800 mg sulfamethoxazole).'}, {'id': 'OG001', 'title': 'Chloroquine (CQ) Prophylaxis', 'description': 'Participants will discontinue standard of care trimethoprim sulfamethoxazol prophylaxis and start weekly CQ prophylaxis at 300 mg.'}, {'id': 'OG002', 'title': 'Discontinuation of Standard of Care (Control Arm)', 'description': 'Participants will discontinue standard of care trimethoprim sulfamethoxazol prophylaxis and receive no prophylaxis.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.0', 'groupId': 'OG000'}, {'value': '5.7', 'groupId': 'OG001'}, {'value': '5.8', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<=0.05', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.47', 'ciLowerLimit': '1.07', 'ciUpperLimit': '2.00', 'pValueComment': 'No adjustments for multiple comparisons were made.', 'statisticalMethod': 'Poisson', 'nonInferiorityType': 'NON_INFERIORITY', 'statisticalComment': "Rate ratio confidence intervals and p-values were adjusted for overdispersion using the Pearson's chi-square scale.", 'nonInferiorityComment': 'Will assess performance of each experimental group relative to TS with a noninferiority margin for 1-HR of 0.35 to test the null (1-HR ≥ 0.35) and alternative (1-HR \\< 0.35) hypotheses. Each experimental group will be declared noninferior to TS if the upper bound of the 95% confidence interval of 1-HR is below 0.35. For ease of interpretation, the HRs have been recast with TS as the reference group, such that HRs greater than 1 indicate an increase in the experimental hazard rate relative to TS.'}, {'pValue': '<=0.05', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.43', 'ciLowerLimit': '1.04', 'ciUpperLimit': '1.96', 'pValueComment': 'No adjustments for multiple comparisons were made.', 'statisticalMethod': 'Poisson', 'nonInferiorityType': 'NON_INFERIORITY', 'statisticalComment': "Rate ratio confidence intervals and p-values were adjusted for overdispersion using the Pearson's chi-square scale.", 'nonInferiorityComment': 'Will assess performance of each experimental group relative to TS with a noninferiority margin for 1-HR of 0.35 to test the null (1-HR ≥ 0.35) and alternative (1-HR \\< 0.35) hypotheses. Each experimental group will be declared noninferior to TS if the upper bound of the 95% confidence interval of 1-HR is below 0.35. For ease of interpretation, the HRs have been recast with TS as the reference group, such that HRs greater than 1 indicate an increase in the experimental hazard rate relative to TS.'}], 'paramType': 'NUMBER', 'timeFrame': '32-66 months', 'description': 'Incidence of any WHO HIV stage 2, 3, or 4 illness', 'unitOfMeasure': 'Events per 100 participant-years', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Bacterial Infections and Malaria', 'denoms': [{'units': 'Participants', 'counts': [{'value': '500', 'groupId': 'OG000'}, {'value': '500', 'groupId': 'OG001'}, {'value': '499', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard of Care Trimethoprim Sulfamethoxazol (TS) Prophylaxis', 'description': 'Participants will continue standard of care daily TS prophylaxis (two tablets each of 80 mg trimethoprim and 400 mg sulfamethoxazole or one tablet each of 160 mg trimethoprim and 800 mg sulfamethoxazole).'}, {'id': 'OG001', 'title': 'Chloroquine (CQ) Prophylaxis', 'description': 'Participants will discontinue standard of care trimethoprim sulfamethoxazol prophylaxis and start weekly CQ prophylaxis at 300 mg.'}, {'id': 'OG002', 'title': 'Discontinuation of Standard of Care (Control Arm)', 'description': 'Participants will discontinue standard of care trimethoprim sulfamethoxazol prophylaxis and receive no prophylaxis.'}], 'classes': [{'categories': [{'measurements': [{'value': '27.8', 'groupId': 'OG000'}, {'value': '37.4', 'groupId': 'OG001'}, {'value': '36.3', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<=0.05', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.31', 'ciLowerLimit': '1.11', 'ciUpperLimit': '1.55', 'pValueComment': 'No adjustments for multiple comparisons were made.', 'statisticalMethod': 'Poisson', 'nonInferiorityType': 'NON_INFERIORITY', 'statisticalComment': "Rate ratio confidence intervals and p-values were adjusted for overdispersion using the Pearson's chi-square scale.", 'nonInferiorityComment': 'Will assess performance of each experimental group relative to TS with a noninferiority margin for 1-HR of 0.35 to test the null (1-HR ≥ 0.35) and alternative (1-HR \\< 0.35) hypotheses. Each experimental group will be declared noninferior to TS if the upper bound of the 95% confidence interval of 1-HR is below 0.35. For ease of interpretation, the HRs have been recast with TS as the reference group, such that HRs greater than 1 indicate an increase in the experimental hazard rate relative to TS.'}, {'pValue': '<=0.05', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.34', 'ciLowerLimit': '1.14', 'ciUpperLimit': '1.58', 'pValueComment': 'No adjustments for multiple comparisons were made.', 'statisticalMethod': 'Poisson', 'nonInferiorityType': 'NON_INFERIORITY', 'statisticalComment': "Rate ratio confidence intervals and p-values were adjusted for overdispersion using the Pearson's chi-square scale.", 'nonInferiorityComment': 'Will assess performance of each experimental group relative to TS with a noninferiority margin for 1-HR of 0.35 to test the null (1-HR ≥ 0.35) and alternative (1-HR \\< 0.35) hypotheses. Each experimental group will be declared noninferior to TS if the upper bound of the 95% confidence interval of 1-HR is below 0.35. For ease of interpretation, the HRs have been recast with TS as the reference group, such that HRs greater than 1 indicate an increase in the experimental hazard rate relative to TS.'}], 'paramType': 'NUMBER', 'timeFrame': '32-66 months', 'description': 'Incidence of bacterial infections and malaria', 'unitOfMeasure': 'Events per 100 participant-years', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Adverse Events Greater Than or Equal to Grade 3 That Are Related to the Study Product', 'denoms': [{'units': 'Participants', 'counts': [{'value': '500', 'groupId': 'OG000'}, {'value': '500', 'groupId': 'OG001'}, {'value': '499', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard of Care Trimethoprim Sulfamethoxazol (TS) Prophylaxis', 'description': 'Participants will continue standard of care daily TS prophylaxis (two tablets each of 80 mg trimethoprim and 400 mg sulfamethoxazole or one tablet each of 160 mg trimethoprim and 800 mg sulfamethoxazole).'}, {'id': 'OG001', 'title': 'Chloroquine (CQ) Prophylaxis', 'description': 'Participants will discontinue standard of care trimethoprim sulfamethoxazol prophylaxis and start weekly CQ prophylaxis at 300 mg..'}, {'id': 'OG002', 'title': 'Discontinuation of Standard of Care (Control Arm)', 'description': 'Participants will discontinue standard of care trimethoprim sulfamethoxazol prophylaxis and receive no prophylaxis.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.24', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '32-66 months', 'description': 'Occurrence of adverse events that are greater than or equal to Grade 3 that require discontinuation of TS or CQ prophylaxis', 'unitOfMeasure': 'Events per 100 participant-years', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Bacterial or Malaria Infection With CQ or TS Resistant Organism', 'timeFrame': '32-66 months', 'description': 'Occurrence of bacterial or malaria infection with CQ or TS resistant organism', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Clinical and Parasitological Response to Antimalarial Therapy', 'timeFrame': '32-66 months', 'description': 'Clinical and parasitological response to antimalarial therapy in cases of uncomplicated malaria', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Standard of Care Trimethoprim Sulfamethoxazol (TS) Prophylaxis', 'description': 'Participants will continue standard of care daily TS prophylaxis (two tablets each of 80 mg trimethoprim and 400 mg sulfamethoxazole or one tablet each of 160 mg trimethoprim and 800 mg sulfamethoxazole).'}, {'id': 'FG001', 'title': 'Chloroquine (CQ) Prophylaxis', 'description': 'Participants will discontinue standard of care trimethoprim sulfamethoxazol prophylaxis and start weekly CQ prophylaxis at 300 mg.'}, {'id': 'FG002', 'title': 'Discontinuation of Standard of Care (Control Arm)', 'description': 'Participants will discontinue standard of care trimethoprim sulfamethoxazol prophylaxis and receive no prophylaxis.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '500'}, {'groupId': 'FG001', 'numSubjects': '500'}, {'groupId': 'FG002', 'numSubjects': '499'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '417'}, {'groupId': 'FG001', 'numSubjects': '408'}, {'groupId': 'FG002', 'numSubjects': '424'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '83'}, {'groupId': 'FG001', 'numSubjects': '92'}, {'groupId': 'FG002', 'numSubjects': '75'}]}], 'dropWithdraws': [{'type': 'Migration out of study area', 'reasons': [{'groupId': 'FG000', 'numSubjects': '61'}, {'groupId': 'FG001', 'numSubjects': '71'}, {'groupId': 'FG002', 'numSubjects': '56'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '13'}, {'groupId': 'FG002', 'numSubjects': '6'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '8'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'Non-compliant participant', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '500', 'groupId': 'BG000'}, {'value': '500', 'groupId': 'BG001'}, {'value': '499', 'groupId': 'BG002'}, {'value': '1499', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Standard of Care Trimethoprim Sulfamethoxazol (TS) Prophylaxis', 'description': 'Participants will continue standard of care daily TS prophylaxis (two tablets each of 80 mg trimethoprim and 400 mg sulfamethoxazole or one tablet each of 160 mg trimethoprim and 800 mg sulfamethoxazole).'}, {'id': 'BG001', 'title': 'Chloroquine (CQ) Prophylaxis', 'description': 'Participants will discontinue standard of care trimethoprim sulfamethoxazol prophylaxis and start weekly CQ prophylaxis at 300 mg..'}, {'id': 'BG002', 'title': 'Discontinuation of Standard of Care (Control Arm)', 'description': 'Participants will discontinue standard of care trimethoprim sulfamethoxazol prophylaxis and receive no prophylaxis.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '494', 'groupId': 'BG000'}, {'value': '496', 'groupId': 'BG001'}, {'value': '480', 'groupId': 'BG002'}, {'value': '1470', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}, {'value': '29', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '39.1', 'spread': '9.7', 'groupId': 'BG000'}, {'value': '38.7', 'spread': '9.6', 'groupId': 'BG001'}, {'value': '39.4', 'spread': '10.1', 'groupId': 'BG002'}, {'value': '39.1', 'spread': '9.8', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '375', 'groupId': 'BG000'}, {'value': '374', 'groupId': 'BG001'}, {'value': '386', 'groupId': 'BG002'}, {'value': '1135', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '125', 'groupId': 'BG000'}, {'value': '126', 'groupId': 'BG001'}, {'value': '113', 'groupId': 'BG002'}, {'value': '364', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '500', 'groupId': 'BG000'}, {'value': '500', 'groupId': 'BG001'}, {'value': '499', 'groupId': 'BG002'}, {'value': '1499', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Malawi', 'categories': [{'measurements': [{'value': '500', 'groupId': 'BG000'}, {'value': '500', 'groupId': 'BG001'}, {'value': '499', 'groupId': 'BG002'}, {'value': '1499', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-09-02', 'size': 702853, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-07-23T09:29', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1499}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2018-07-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-07-26', 'studyFirstSubmitDate': '2012-07-06', 'resultsFirstSubmitDate': '2019-08-22', 'studyFirstSubmitQcDate': '2012-07-23', 'lastUpdatePostDateStruct': {'date': '2022-07-28', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-04-28', 'studyFirstPostDateStruct': {'date': '2012-07-26', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-05-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-07-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Bacterial or Malaria Infection With CQ or TS Resistant Organism', 'timeFrame': '32-66 months', 'description': 'Occurrence of bacterial or malaria infection with CQ or TS resistant organism'}, {'measure': 'Clinical and Parasitological Response to Antimalarial Therapy', 'timeFrame': '32-66 months', 'description': 'Clinical and parasitological response to antimalarial therapy in cases of uncomplicated malaria'}], 'primaryOutcomes': [{'measure': 'Severe Events', 'timeFrame': '22-66 months', 'description': 'Incidence of severe events (composite of death and WHO stage 3 and 4 illness)'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With at Least One Detectable HIV Viral Load', 'timeFrame': 'Throughout study participation, measured every six months (2-5.5 years).', 'description': 'Number of participants who ever have a detectable viral load (\\>400 copies/ml).'}, {'measure': 'CD4 Cell Count', 'timeFrame': 'Every 6 months for 22-66 months', 'description': 'Number of Participants with at Least One CD4 Count \\<200'}, {'measure': 'WHO HIV Stage 2, 3, 4 Illness', 'timeFrame': '32-66 months', 'description': 'Incidence of any WHO HIV stage 2, 3, or 4 illness'}, {'measure': 'Bacterial Infections and Malaria', 'timeFrame': '32-66 months', 'description': 'Incidence of bacterial infections and malaria'}, {'measure': 'Adverse Events Greater Than or Equal to Grade 3 That Are Related to the Study Product', 'timeFrame': '32-66 months', 'description': 'Occurrence of adverse events that are greater than or equal to Grade 3 that require discontinuation of TS or CQ prophylaxis'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Malaria', 'HIV', 'Prophylaxis', 'Antiretroviral therapy'], 'conditions': ['HIV']}, 'referencesModule': {'references': [{'pmid': '33744963', 'type': 'BACKGROUND', 'citation': 'Laurens MB, Mungwira RG, Nampota N, Nyirenda OM, Divala TH, Kanjala M, Mkandawire FA, Galileya LT, Nyangulu W, Mwinjiwa E, Downs M, Tillman A, Taylor TE, Mallewa J, Plowe CV, van Oosterhout JJ, Laufer MK. Revisiting Co-trimoxazole Prophylaxis for African Adults in the Era of Antiretroviral Therapy: A Randomized Controlled Clinical Trial. Clin Infect Dis. 2021 Sep 15;73(6):1058-1065. doi: 10.1093/cid/ciab252.'}, {'pmid': '35848575', 'type': 'DERIVED', 'citation': 'Mungwira RG, Laurens MB, Nyangulu W, Divala TH, Nampota-Nkomba N, Buchwald AG, Nyirenda OM, Mwinjiwa E, Kanjala M, Galileya LT, Earland DE, Adams M, Plowe CV, Taylor TE, Mallewa J, van Oosterhout JJ, Laufer MK; TSCQ Study Team. High burden of malaria among Malawian adults on antiretroviral therapy after discontinuing prophylaxis. AIDS. 2022 Oct 1;36(12):1675-1682. doi: 10.1097/QAD.0000000000003317. Epub 2022 Jul 15.'}, {'pmid': '27431995', 'type': 'DERIVED', 'citation': 'Laurens MB, Mungwira RG, Nyirenda OM, Divala TH, Kanjala M, Muwalo F, Mkandawire FA, Tsirizani L, Nyangulu W, Mwinjiwa E, Taylor TE, Mallewa J, Blackwelder WC, Plowe CV, Laufer MK, van Oosterhout JJ. TSCQ study: a randomized, controlled, open-label trial of daily trimethoprim-sulfamethoxazole or weekly chloroquine among adults on antiretroviral therapy in Malawi: study protocol for a randomized controlled trial. Trials. 2016 Jul 18;17(1):322. doi: 10.1186/s13063-016-1392-3.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine if there is a benefit to taking trimethoprim-sulfamethoxazole (TS) as prophylaxis among HIV positive adults who have viral load suppression and a good clinical response on anti-retroviral therapy (ART). If there is a benefit, then is it due to antimalarial or antibacterial properties.\n\nThe investigators hypothesize that there will be a long-term benefit on survival and disease control in the context of prophylaxis and that the benefit will largely be attributed to prevention of malaria. The main study hypothesis is that 1)TS and chloroquine (CQ) will decrease the rates of morbidity and mortality among adults after 6 or more months of ART and 2) CQ prophylaxis will be associated with more prolonged viral suppression and higher CD4 cell counts than TS prophylaxis or no prophylaxis.', 'detailedDescription': 'This is a randomized, controlled, open-label, phase III trial of standard of care TS prophylaxis and CQ prophylaxis compared to no prophylaxis in adults receiving ART. Adults who have been receiving ART for at least six months with a good clinical response and provide informed consent and fulfill the eligibility criteria will be randomized to one of three arms: (1) to continue standard of care trimethoprim-sulfamethoxazole (TS) prophylaxis, (2) discontinue standard of care TS prophylaxis and begin weekly CQ prophylaxis or (3) discontinue standard of care TS prophylaxis. Participants will be asked to return to the research clinic every four weeks for the first 24 weeks then every 12 weeks thereafter, and any time they are ill to facilitate both active and passive follow-up of the study endpoints. Participation will last for 32 to approximately 66 months. Participants who develop a WHO clinical stage 3 or 4 illness, experience a sustained decline in their CD4 count below 200 cells/mm3, or who experience ART failure will be placed on standard of care TS prophylaxis. Those with confirmed ART failure will be evaluated for second-line therapy according to the Malawi Ministry of Health guidelines.\n\nThe study population will include up to 1500 Malawian adults aged 18 years or older living with HIV in or near Blantyre or Zomba, Malawi, Central Africa who have been receiving antiretroviral therapy for at least 6 months with good clinical response to ART, have an undetectable HIV viral load and a CD4 count \\>250/mm3.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 years or older\n* Documented HIV-1 infection\n* Initiation of ART through a government-sponsored ART program at least six months prior\n* Undetectable HIV viral load (\\< 400 copies/mL)\n* CD4 count \\> 250/mm3\n* TS prophylaxis prescribed for at least the previous 2 months\n* Intention to remain in the study area until the end of the study period\n* Informed consent from participant\n* Female study volunteers of reproductive potential must have a negative urine pregnancy test performed within 20 days before randomization.\n* Female study volunteers of reproductive potential who participate in sexual activity that could lead to pregnancy must use contraception (male or female condoms, diaphragm or cervical cap with spermicide, intrauterine device, or hormone-based contraceptive) while receiving their assigned study drug and for one month after stopping the medications.\n\nExclusion Criteria:\n\n* Severe acute illness (defined as requiring hospitalization at the time of screening or other conditions such as laboratory abnormalities as determined by the investigators)\n* Chronic treatment (requiring therapy for \\> 14 days) or secondary prophylaxis (for toxoplasmosis, Pneumocystis pneumonia, or tuberculosis for example) with any drug with antimalarial or antibacterial activity\n* History of hypersensitivity to antifolate drugs or CQ\n* Laboratory exclusion criteria\n* Hemoglobin \\< 8.0 gm/dL\n* Platelet count \\< 50,000/mm3\n* Absolute granulocyte count \\< 500/mm3\n* Serum alanine aminotransferase (ALT) concentration \\> 210 U/L for men, \\>160 U/L for women\n* Serum creatinine concentration \\> 3.3mg/dl (291.7µmol/L) for men, and \\> 2.7mg/dl (238.7µmol/L) for women)\n* History of visual field or retinal changes\n* History of preexisting auditory damage\n* History of porphyria\n* History of psoriasis\n* History of liver disease\n* History of seizure disorder\n* History of glucose-6-phosphate dehydrogenase (G6PD) deficiency\n* History of ECG and cardiac conduction abnormality or cardiomyopathy\n* History of myopathy'}, 'identificationModule': {'nctId': 'NCT01650558', 'acronym': 'TSCQ', 'briefTitle': 'Daily Trimethoprim-sulfamethoxazole or Weekly Chloroquine Among Adults on ART in Malawi', 'organization': {'class': 'OTHER', 'fullName': 'University of Maryland, Baltimore'}, 'officialTitle': 'Randomized, Open-label Controlled Trial of Daily Trimethoprim-sulfamethoxazole or Weekly Chloroquine Among Adults on Anti-retroviral Therapy in Malawi', 'orgStudyIdInfo': {'id': 'HP-00043360; DAIDS ES-10822'}, 'secondaryIdInfos': [{'id': 'U01AI089342-01A1', 'link': 'https://reporter.nih.gov/quickSearch/U01AI089342-01A1', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Standard of Care Prophylaxis (TS)', 'description': 'Standard of care prophylaxis with daily trimethoprim sulfamethoxazole (TS).', 'interventionNames': ['Drug: Standard of Care prophylaxis']}, {'type': 'EXPERIMENTAL', 'label': 'Chloroquine (CQ) prophylaxis', 'description': 'Discontinuation of standard of care TS prophylaxis and starting weekly chloroquine prophylaxis', 'interventionNames': ['Drug: Chloroquine (CQ) prophylaxis']}, {'type': 'NO_INTERVENTION', 'label': 'Discontinuation of standard of care', 'description': 'Control arm - Discontinuation of standard of care trimethoprim sulfamethoxazole.'}], 'interventions': [{'name': 'Standard of Care prophylaxis', 'type': 'DRUG', 'otherNames': ['Bactrim', 'Co-trimoxazole'], 'description': 'Daily trimethoprim sulfamethoxazole', 'armGroupLabels': ['Standard of Care Prophylaxis (TS)']}, {'name': 'Chloroquine (CQ) prophylaxis', 'type': 'DRUG', 'otherNames': ['Aralen'], 'description': 'Discontinue standard of care and start weekly CQ.', 'armGroupLabels': ['Chloroquine (CQ) prophylaxis']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Blantyre', 'country': 'Malawi', 'facility': 'Blantyre Malaria Project Research Clinic', 'geoPoint': {'lat': -15.78499, 'lon': 35.00854}}, {'city': 'Zomba', 'country': 'Malawi', 'facility': 'Tisungane Clinic', 'geoPoint': {'lat': -15.38596, 'lon': 35.3188}}], 'overallOfficials': [{'name': 'Miriam K Laufer, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Maryland, Baltimore'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Maryland, Baltimore', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Allergy and Infectious Diseases (NIAID)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Pediatrics', 'investigatorFullName': 'Miriam Laufer', 'investigatorAffiliation': 'University of Maryland, Baltimore'}}}}