A Study to Provide Continued Access to Study Drug to Children and Adolescents Who Have Completed Clinical Studies Involving Gilead HIV Treatments
NCT ID: NCT06337032
Last Updated: 2025-11-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
350 participants
INTERVENTIONAL
2024-08-27
2034-03-31
Brief Summary
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The primary objectives of this study are as follows:
* To provide continued access to the study drug received in the parent protocol or switch to bictegravir/emtricitabine/tenofovir (B/F/TAF) for participants who completed a Gilead parent study evaluating drugs for HIV treatment.
* To evaluate the safety of the study drug(s) in participants with HIV-1.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Rollover from Parent Study: GS-US-311-1269: Parent Study Drug (F/TAF) or B/F/TAF
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.
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
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
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
Rollover from Parent Study: GS-US-292-0106: Parent Study Drug (E/C/F/TAF) or B/F/TAF
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.
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
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
Rollover Parent Study GS-US-216-0128: Parent Study Drug (Combination Drugs) or B/F/TAF
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.
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
F/TAF (High Dose Tablet)
200/25 mg fixed-dose combination (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
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
Rollover from Parent Studies: GS-US-380-1474 and CO-US-380-5578: Parent Study Drug (B/F/TAF)
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.
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
Interventions
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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
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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Note: individuals planning to switch after Day 1 must not have plasma HIV RNA ≥ 50 copies/mL (or detectable HIV-1 RNA level according to the local assay being used if the limit of detection is ≥ 50 copies/mL).
* Individuals planning to switch to B/F/TAF must not have any ongoing Grade 3 or 4 drug-related AE or clinically relevant Grade 3 or 4 drug-related laboratory abnormality (confirmed on repeat) related to any component of B/F/TAF prior to treatment switch.
* For those on B/F/TAF or planning to switch to B/F/TAF: previous treatment discontinuation of any component of B/F/TAF due to toxicity or intolerance.
* For those planning to switch to B/F/TAF: known hypersensitivity to any component of the study drug, its metabolites, or formulation excipients.
* Ongoing treatment with or prior use of any prohibited medications.
1 Month
ALL
No
Sponsors
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Gilead Sciences
INDUSTRY
Responsible Party
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Principal Investigators
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Gilead Study Director
Role: STUDY_DIRECTOR
Gilead Sciences
Locations
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Helios Salud
Buenos Aires, , Argentina
Hospital del Niño
Panama City, , Panama
University of Stellenbosch
Cape Town, , South Africa
Enhancing Care Foundation
Durban, , South Africa
WITS RHI Research Centre
Johannesburg, , South Africa
Rahima Moosa Mother and Child Hospital
Johannesburg, , South Africa
Be Part Yoluntu Centre
Paarl, , South Africa
The Aurun Institute
Pretoria, , South Africa
Perinatal HIV Research Unit
Soweto, , South Africa
Faculty of Medicine - Mahidol University
Bangkok Noi, , Thailand
Khon Kaen University
Khon Kaen, , Thailand
Joint Clinical Research Centre
Kampala, , Uganda
Baylor College of Medicine
Kampala, , Uganda
University of Zimbabwe Clinical Research Centre
Harare, , Zimbabwe
Countries
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Central Contacts
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Related Links
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Gilead Clinical Trials Website
Other Identifiers
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GS-US-380-6684
Identifier Type: -
Identifier Source: org_study_id
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