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NCT Number: NCT06337032

A Study to Provide Continued Access to Study Drug to Children and Adolescents Who Have Completed Clinical Studies Involving Gilead HIV Treatments

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.

Recruiting

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Key information

Conditions

Age range

1 month and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Helios Salud, Buenos Aires, Argentina

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria:

  • Completed an applicable parent study: GS-US-292-0106, GS-US-380-1474, GS-US-311-1269, or GS-US-216-0128, and gave consent to study participation.

Key Exclusion Criteria:

  • Individuals planning to switch to B/F/TAF on Day 1 with plasma HIV RNA ≥ 50 copies/mL during the last parent study visit prior to screening/Day 1 visit.
  • 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 with 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.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Treatment and study plan

F/TAF (High Dose Tablet)

Drug

200/25 mg fixed-dose combination (FDC) tablet administered orally

Other names: Descovy®

F/TAF (Low Dose Tablet)

Drug

200/10 mg FDC tablet administered orally

F/TAF (Lowest Dose Tablet)

Drug

120/15 mg FDC tablet administered orally

F/TAF (High Dose TOS)

Drug

60/7.5 mg tablet for oral suspension (TOS) administered orally

F/TAF (Low Dose TOS)

Drug

30/3.75 mg TOS administered orally

F/TAF (Lowest Dose TOS)

Drug

15/1.88 mg TOS administered orally

E/C/F/TAF

Drug

150/150/200/10 mg tablet administered orally

Other names: Genvoya®

E/C/F/TAF (Low Dose)

Drug

90/90/120/6 mg tablet administered orally

Cobicistat (High Dose)

Drug

150 mg tablet administered orally

Other names: GS-9350, Tybost®

Cobicistat (Low Dose)

Drug

90 mg tablet administered orally

Other names: GS-9350

Cobicistat (TOS)

Drug

30 mg TOS administered orally

Other names: GS-9350

B/F/TAF (High Dose)

Drug

50/200/25 mg FDC tablet administered orally

Other names: Biktarvy®, GS-9883/F/TAF

B/F/TAF (Low Dose)

Drug

30/120/15 mg FDC tablet administered orally

Other names: GS-9883/F/TAF

B/F/TAF (High Dose TOS)

Drug

15/60/7.52 mg TOS administered orally

Other names: GS-9883/F/TAF

B/F/TAF (Low Dose TOS)

Drug

7.5/30/3.76 mg TOS administered orally

Other names: GS-9883/F/TAF

B/F/TAF (Lowest Dose TOS)

Drug

3.76/15/1.88 mg TOS administered orally

Other names: GS-9883/F/TAF

3rd ARV Agent

Drug

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)

Drug

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

Drug

Administered according to the prescribing information

DRV

Drug

Administered according to the prescribing information

Lopinavir Boosted with ritonavir (LPV/r)

Drug

Administered according to the prescribing information

Primary outcomes

  1. Number of Eligible Participants Who Have Received Access to the Study Drug(s) in the Study

    Time frame: Up to 9.5 Years

Secondary outcomes

  1. Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs)

    Time frame: Up to 9.5 Years

Study contacts

Contact information is provided by the study sponsor or research team.

Gilead Clinical Study Information Center

CONTACT

[email protected]

1-833-445-3230 (GILEAD-0)

Sponsors and collaborators

Lead sponsor

Gilead Sciences

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2034
Study completion
2034
First posted
Mar 29, 2024
Registry last updated
Jun 10, 2026

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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