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

March 22, 2024 updated by: Gilead Sciences

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

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.

Study Overview

Study Type

Interventional

Enrollment (Estimated)

350

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

Key Inclusion Criteria:

  • Completed an applicable parent study: GS-US-292-0106, GS-US-380-1474, GS-US-311-1269, GS-US-216-0128, or CO-US-380-5578 and gave consent to study participation.

Key Exclusion Criteria:

  • Individuals planning to switch to B/F/TAF on Day 1 cannot have 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 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.

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.

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
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
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
Experimental: 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.

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
150/150/200/10 mg tablet administered orally
Other Names:
  • Genvoya®
90/90/120/6 mg tablet administered orally
Experimental: 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.

200/25 mg fixed-dose combination (FDC) tablet administered orally
Other Names:
  • Descovy®
120/15 mg FDC tablet administered orally
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
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
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 mg tablet administered orally
Other Names:
  • Tybost®
  • GS-9350
90 mg tablet administered orally
Other Names:
  • GS-9350
30 mg TOS administered orally
Other Names:
  • GS-9350
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
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
Experimental: 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.
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of Eligible Participants Who Have Received Access to the Study Drug(s) in the Study
Time Frame: Up to 9.5 Years
Up to 9.5 Years

Secondary Outcome Measures

Outcome Measure
Time Frame
Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs)
Time Frame: Up to 9.5 Years
Up to 9.5 Years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Study Director: Gilead Study Director, Gilead Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2024

Primary Completion (Estimated)

March 1, 2034

Study Completion (Estimated)

March 1, 2034

Study Registration Dates

First Submitted

March 22, 2024

First Submitted That Met QC Criteria

March 22, 2024

First Posted (Actual)

March 29, 2024

Study Record Updates

Last Update Posted (Actual)

March 29, 2024

Last Update Submitted That Met QC Criteria

March 22, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on HIV-1-infection

Clinical Trials on F/TAF (High Dose Tablet)

3
Subscribe