205
Participants
Start Date
September 1, 2021
Primary Completion Date
April 24, 2025
Study Completion Date
July 10, 2025
Bictegravir (BIC)
Administered consistent with the package inserts and/or instructions provided by the non-study sources who prescribe or supply the drugs to participants
Tenofovir alafenamide (TAF)
Administered consistent with the package inserts and/or instructions provided by the non-study sources who prescribe or supply the drugs to participants
Cabotegravir (CAB)
Administered consistent with the package inserts and/or instructions provided by the non-study sources who prescribe or supply the drugs to participants
Dolutegravir (DTG)
Administered consistent with the package inserts and/or instructions provided by the non-study sources who prescribe or supply the drugs to participants
Atazanavir/ritonavir (ATV/r)
Administered consistent with the package inserts and/or instructions provided by the non-study sources who prescribe or supply the drugs to participants
Darunavir/ritonavir (DRV/r)
Administered consistent with the package inserts and/or instructions provided by the non-study sources who prescribe or supply the drugs to participants
Lopinavir/ritonavir (LPV/r)
Administered consistent with the package inserts and/or instructions provided by the non-study sources who prescribe or supply the drugs to participants
Cobicistat
Administered consistent with the package inserts and/or instructions provided by the non-study sources who prescribe or supply the drugs to participants
Ritonavir
Administered consistent with the package inserts and/or instructions provided by the non-study sources who prescribe or supply the drugs to participants
First-Line TB Treatment
"Participants will be receiving first-line TB treatment with at least two of the following TB treatment drugs: isoniazid (INH), rifampin (RIF), rifabutin (RFB), ethambutol (EMB), pyrazinamide (PZA), or moxifloxacin (MFX).~Drugs will be administered consistent with the package inserts and/or instructions provided by the non-study sources who prescribe or supply the drugs to participants."
Second-Line TB Treatment
"Participants will be receiving second-line TB treatment with at least one of the following second-line TB treatment drugs:~* Levofloxacin (LFX) 750mg - 1000mg q.d.~* Clofazimine (CFZ) 100mg q.d.~* Linezolid (LZD) 300mg - 600mg q.d.~* Bedaquiline (BDQ) 200mg three times per week (t.i.w.)~* Delamanid (DLM) 100mg b.i.d.~* Moxifloxacin (MFX) 400mg or 800mg q.d., and at least one other second-line TB treatment drug under study~Drugs will be administered consistent with the package inserts and/or instructions provided by the non-study sources who prescribe or supply the drugs to participants."
Doravirine (DOR)
Administered consistent with the package inserts and/or instructions provided by the non-study sources who prescribe or supply the drugs to participants
Wits RHI Shandukani Research, Johannesburg
Desmond Tutu TB Centre - Stellenbosch University (DTTC-SU) CRS, Cape Town
Famcru Crs, Tygerberg Hills
Bronx-Lebanon Hospital Center NICHD CRS, The Bronx
Jacobi Med. Ctr. Bronx NICHD CRS, The Bronx
Siriraj Hospital, Mahidol University NICHD CRS, Bangkok
Kenya Medical Research Institute / Walter Reed Project Clinical Research Center, Kericho CRS, Kericho
Johns Hopkins Univ. Baltimore NICHD CRS, Baltimore
Hosp. Geral De Nova Igaucu Brazil NICHD CRS, Rio de Janeiro
Emory University School of Medicine NICHD CRS, Atlanta
University of Florida Jacksonville NICHD CRS, Jacksonville
Pediatric Perinatal HIV NICHD CRS, Miami
South Florida CDTC Ft Lauderdale NICHD CRS, Fort Lauderdale
Rush University Cook County Hospital Chicago NICHD CRS, Chicago
Lurie Children's Hospital of Chicago (LCH) CRS (Site ID: 4001), Chicago
Univ. of Colorado Denver NICHD CRS, Aurora
Usc La Nichd Crs, Los Angeles
University of California, UC San Diego CRS- Mother-Child-Adolescent HIV Program, San Diego
Byramjee Jeejeebhoy Medical College (BJMC) CRS, Pune
David Geffen School of Medicine at UCLA NICHD CRS, Los Angeles
Hospital Federal dos Servidores do Estado NICHD CRS, Rio de Janeiro
IMPAACT/ Gamma Project/ UPR Pediatric HIV/AIDS Research CRS, San Juan
Baylor-Uganda CRS, Kampala
Collaborators (2)
International Maternal Pediatric Adolescent AIDS Clinical Trials Group
NETWORK
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
National Institute of Mental Health (NIMH)
NIH
Gilead Sciences
INDUSTRY
ViiV Healthcare
INDUSTRY
Merck Sharp & Dohme LLC
INDUSTRY
National Institute of Allergy and Infectious Diseases (NIAID)
NIH