A Phase 4 interventional study of F/TAF (High Dose Tablet) and F/TAF (Low Dose Tablet) in HIV-1-infection, sponsored by Gilead Sciences. Recruiting at 17 sites in 6 countries. Open to participants aged 1 Month and older. Per ClinicalTrials.gov, last updated 2026-11-06.
Sponsored by Gilead Sciences · Phase 4, Interventional, and Treatment
The goal of this clinical study is to provide continued access to the study drug(s) to children and adolescents with human immunodeficiency virus type 1 (HIV-1) who completed their participation in an applicable parent study and to monitor for adverse events.
The primary objectives of this study are as follows:
Gilead Sciences is the lead sponsor of 692 studies on the registry; 26 are open to participants now.
Of its 261 completed or terminated interventional studies of FDA-regulated products, 251 (96%) have results posted.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Key Exclusion Criteria:
Individuals planning to switch to B/F/TAF on Day 1 with plasma RNA ≥ 50 copies/mL during the last parent study visit prior to screening/Day 1 visit.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will continue to take the study drug they were taking in the parent study, emtricitabine/tenofovir alafenamide (F/TAF) along with a 3rd antiretroviral (ARV) agent. The dose of F/TAF will be based on the weight of the participant, ranging between 120/15 mg to 200/25 mg. The dose of F/TAF will be different when given with the boosted and the unboosted 3rd ARV agent: F/TAF (High Dose Tablet) for unboosted 3rd ARV agent; F/TAF (Low Dose Tablet) for the boosted 3rd ARV agent. Participants may switch to B/F/TAF, at a dose based on participant's weight.
Drug: F/TAF (High Dose Tablet) · Drug: F/TAF (Low Dose Tablet) · Drug: F/TAF (Lowest Dose Tablet) · Drug: B/F/TAF (High Dose) · Drug: B/F/TAF (Low Dose) · Drug: B/F/TAF (High Dose TOS) · Drug: 3rd ARV Agent
Participants will continue to take the study drug they were taking in the parent study, elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF). The dose of E/C/F/TAF will be based on the weight of the participant, ranging between 90/90/120/6 mg to 150/150/200/10 mg. Participants may switch to B/F/TAF at a dose based on participant's weight.
Drug: E/C/F/TAF · Drug: E/C/F/TAF (Low Dose) · Drug: B/F/TAF (High Dose) · Drug: B/F/TAF (Low Dose)
Participants will continue to take the following study drugs they were taking in the parent study: * Cobicistat (COBI) + DRV + NRTI backbone * COBI + ATV + NRTI backbone * F/TAF + DRV+ COBI * F/TAF + ATV+ COBI * F/TAF + LPV/r * F/TAF + 3rd unboosted agent The dose of F/TAF will be based on the weight of the participant, ranging between 15/1.88 mg and 200/25 mg, once daily. Additionally, the dose of COBI will be based on the weight of the participant, ranging between 30 mg and 150 mg, once or twice daily. Participants may switch to B/F/TAF at a dose based on participant's weight.
Drug: F/TAF (High Dose Tablet) · Drug: F/TAF (Lowest Dose Tablet) · Drug: F/TAF (High Dose TOS) · Drug: F/TAF (Low Dose TOS) · Drug: F/TAF (Lowest Dose TOS) · Drug: Cobicistat (High Dose) · Drug: Cobicistat (Low Dose) · Drug: Cobicistat (TOS) · Drug: B/F/TAF (High Dose) · Drug: B/F/TAF (Low Dose) · Drug: B/F/TAF (High Dose TOS) · Drug: B/F/TAF (Low Dose TOS) · Drug: B/F/TAF (Lowest Dose TOS) · Drug: 3rd ARV Agent · Drug: Nucleos(t)ide reverse transcriptase inhibitors (NRTI) · Drug: ATV · Drug: DRV · Drug: Lopinavir Boosted with ritonavir (LPV/r)
Participants will continue to take the study drug they were taking in the parent study, B/F/TAF. Participants who are diagnosed with HIV-1 infection in parent study CO-US-380-5578 and complete the study drug will continue to take the study drug they were taking in the parent study, B/F/TAF. The dose of B/F/TAF will be based on the weight of the participant.
Drug: B/F/TAF (High Dose) · Drug: B/F/TAF (Low Dose) · Drug: B/F/TAF (High Dose TOS) · Drug: B/F/TAF (Low Dose TOS) · Drug: B/F/TAF (Lowest Dose TOS)
Drug page: Emtricitabine tenofovir alafenamide
200/25 mg fixed-dose combination (FDC) tablet administered orally
Also known as: Descovy®
Drug page: Tenofovir alafenamide
200/10 mg FDC tablet administered orally
Drug page: Tenofovir alafenamide
120/15 mg FDC tablet administered orally
Drug page: Tenofovir alafenamide
60/7.5 mg tablet for oral suspension (TOS) administered orally
Drug page: Tenofovir alafenamide
30/3.75 mg TOS administered orally
Drug page: Tenofovir alafenamide
15/1.88 mg TOS administered orally
Drug pages: Elvitegravir · Cobicistat · Emtricitabine · Tenofovir alafenamide
150/150/200/10 mg tablet administered orally
Also known as: Genvoya®
Drug page: Tenofovir alafenamide
90/90/120/6 mg tablet administered orally
150 mg tablet administered orally
Also known as: GS-9350, Tybost®
90 mg tablet administered orally
Also known as: GS-9350
30 mg TOS administered orally
Also known as: GS-9350
50/200/25 mg FDC tablet administered orally
Also known as: Biktarvy®, GS-9883/F/TAF
Drug page: Tenofovir alafenamide
30/120/15 mg FDC tablet administered orally
Also known as: GS-9883/F/TAF
Drug page: Tenofovir alafenamide
15/60/7.52 mg TOS administered orally
Also known as: GS-9883/F/TAF
Drug page: Tenofovir alafenamide
7.5/30/3.76 mg TOS administered orally
Also known as: GS-9883/F/TAF
Drug page: Tenofovir alafenamide
3.76/15/1.88 mg TOS administered orally
Also known as: GS-9883/F/TAF
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
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)
Administered according to the prescribing information
Administered according to the prescribing information
Administered according to the prescribing information
Number of Eligible Participants Who Have Received Access to the Study Drug(s) in the Study
Time frame: Up to 2.8 Years
Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs)
Time frame: Up to 9.5 Years
Not enrolling at this site.
Not enrolling at this site.
Not enrolling at this site.
Not enrolling at this site.
Plan to share: No
Started Aug 2024 (actual). Primary completion is estimated for Jun 2027, 34 months after the start.
Primary completion moved once since we started tracking on Sep 25, 2026: Mar 2034 → Jun 2027, on Oct 19, 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drugs tested here: Emtricitabine tenofovir alafenamide · Tenofovir alafenamide · Elvitegravir · Cobicistat · Emtricitabine · Atazanavir · Darunavir