F/TAF (High Dose Tablet)
Drug200/25 mg fixed-dose combination (FDC) tablet administered orally
Other names: Descovy®
NCT Number: NCT06337032
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:
* 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.
Interested in participating?
Request Info1 month and older
All sexes
Interventional
Phase 4
Helios Salud, Buenos Aires, Argentina
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Key Inclusion Criteria:
Key Exclusion Criteria:
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
200/25 mg fixed-dose combination (FDC) tablet administered orally
Other names: Descovy®
200/10 mg FDC tablet administered orally
120/15 mg FDC tablet administered orally
60/7.5 mg tablet for oral suspension (TOS) administered orally
30/3.75 mg TOS administered orally
15/1.88 mg TOS administered orally
150/150/200/10 mg tablet administered orally
Other names: Genvoya®
90/90/120/6 mg tablet administered orally
150 mg tablet administered orally
Other names: GS-9350, Tybost®
90 mg tablet administered orally
Other names: GS-9350
30 mg TOS administered orally
Other names: GS-9350
50/200/25 mg FDC tablet administered orally
Other names: Biktarvy®, GS-9883/F/TAF
30/120/15 mg FDC tablet administered orally
Other names: GS-9883/F/TAF
15/60/7.52 mg TOS administered orally
Other names: GS-9883/F/TAF
7.5/30/3.76 mg TOS administered orally
Other names: GS-9883/F/TAF
3.76/15/1.88 mg TOS administered orally
Other names: 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
Time frame: Up to 9.5 Years
Time frame: Up to 9.5 Years
Contact information is provided by the study sponsor or research team.
Gilead Sciences
Industry
An Open-label, Single-arm Study to Provide Continued Access to Study Drug to Participants Who Have Completed Pediatric Clinical Studies Involving Gilead HIV Treatments
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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