350
Participants
Start Date
August 27, 2024
Primary Completion Date
March 31, 2034
Study Completion Date
March 31, 2034
F/TAF (High Dose Tablet)
200/25 mg fixed-dose combination (FDC) tablet administered orally
F/TAF (Low Dose Tablet)
200/10 mg FDC tablet administered orally
F/TAF (Lowest Dose Tablet)
120/15 mg FDC tablet administered orally
F/TAF (High Dose TOS)
60/7.5 mg tablet for oral suspension (TOS) administered orally
F/TAF (Low Dose TOS)
30/3.75 mg TOS administered orally
F/TAF (Lowest Dose TOS)
15/1.88 mg TOS administered orally
E/C/F/TAF
150/150/200/10 mg tablet administered orally
E/C/F/TAF (Low Dose)
90/90/120/6 mg tablet administered orally
Cobicistat (High Dose)
150 mg tablet administered orally
Cobicistat (Low Dose)
90 mg tablet administered orally
Cobicistat (TOS)
30 mg TOS administered orally
B/F/TAF (High Dose)
50/200/25 mg FDC tablet administered orally
B/F/TAF (Low Dose)
30/120/15 mg FDC tablet administered orally
B/F/TAF (High Dose TOS)
15/60/7.52 mg TOS administered orally
B/F/TAF (Low Dose TOS)
7.5/30/3.76 mg TOS administered orally
B/F/TAF (Lowest Dose TOS)
3.76/15/1.88 mg TOS administered orally
3rd ARV Agent
A 3rd antiretroviral (ARV) agent administered as defined by the investigator, according to the prescribing information. A 3rd ARV agent may include: boosted atazanavir (ATV), boosted lopinavir (LPV/r), boosted darunavir (DRV), unboosted efavirenz (EFV), unboosted nevirapine (NVP), unboosted raltegravir (RAL), or unboosted dolutegravir (DTG), or any other unspecified agent that is available in a participant's country
Nucleos(t)ide reverse transcriptase inhibitors (NRTI)
NRTIs administered as defined by the investigator, according to the prescribing information. NRTIs may include zidovudine (ZDV), stavudine (d4T), didanosine (ddI), abacavir (ABC), tenofovir disoproxil fumarate (TDF), tenofovir alafenamide (TAF), lamivudine (3TC), or emtricitabine (FTC)
ATV
Administered according to the prescribing information
DRV
Administered according to the prescribing information
Lopinavir Boosted with ritonavir (LPV/r)
Administered according to the prescribing information
RECRUITING
Perinatal HIV Research Unit, Soweto
RECRUITING
Rahima Moosa Mother and Child Hospital, Johannesburg
RECRUITING
Enhancing Care Foundation, Durban
RECRUITING
University of Stellenbosch, Cape Town
RECRUITING
Be Part Yoluntu Centre, Paarl
RECRUITING
Joint Clinical Research Centre, Kampala
RECRUITING
Faculty of Medicine - Mahidol University, Bangkok Noi
RECRUITING
Khon Kaen University, Khon Kaen
RECRUITING
Helios Salud, Buenos Aires
RECRUITING
Hospital del Niño, Panama City
RECRUITING
The Aurun Institute, Pretoria
RECRUITING
University of Zimbabwe Clinical Research Centre, Harare
Lead Sponsor
Gilead Sciences
INDUSTRY