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

HIV-1-infection Clinical Trial

Official 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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06337032
• Other study ID #: GS-US-380-6684
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: September 2024
• Est. completion date: March 2034

Study information

• Verified date: March 2024
• Source: Gilead Sciences
• Contact: Gilead Clinical Study Information Center
• Phone: 1-833-445-3230 (GILEAD-0)
• Email: GileadClinicalTrials[@]gilead.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 350
• Est. completion date: March 2034
• Est. primary completion date: March 2034
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Month to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• HIV-1-infection

Intervention

Drug:
• 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
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Gilead Sciences

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Eligible Participants Who Have Received Access to the Study Drug(s) in the Study		Up to 9.5 Years
Secondary	Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs)		Up to 9.5 Years