E/C/F/TAF for HIV-1 Infection

Recruiting in Palo Alto (17 mi)

+15 other locations

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2 & 3

Waitlist Available

Sponsor: Gilead Sciences

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?This trial tests a single pill combining four HIV medications in adolescents and children. It aims to find the right dose and ensure safety for those new to treatment and those already on it. The pill works by stopping the virus from growing and spreading.

Eligibility Criteria

This trial is for HIV-1 infected adolescents who haven't had anti-HIV drugs (12-<18 years, over 35kg) and children both new to treatment (6-<12 years, over 25kg) and those already on a stable regimen without resistance to the study drug components. Excluded are those with hepatitis B/C, recent tuberculosis, or pregnant/lactating females.

Inclusion Criteria

I am 12-17 years old, weigh at least 35 kg, have HIV with specific criteria, and have never used HIV drugs.

I am 6-11 years old, weigh at least 55 lbs, have had undetectable HIV for 6 months, and no resistance to my current HIV treatment.

I am over 2 years old, weigh between 31 and 55 lbs, have had undetectable HIV levels for 6 months, and no resistance to my current HIV treatment.

Exclusion Criteria

My liver is severely damaged and not functioning properly.

Pregnant or lactating females

I have an infection with hepatitis B or C.

+1 more

Participant Groups

The trial tests E/C/F/TAF single tablet regimens at standard and low doses in different age groups. It aims to understand how the body processes the medication (pharmacokinetics), confirm dosing for effectiveness, and assess safety over a period of up to 24 weeks.

3Treatment groups

Experimental Treatment

Group I: Cohort 3: Age ≥2 Years and Weight ≥ 14 to <25 kgExperimental Treatment2 Interventions

Virologically suppressed HIV-infected children (≥ 2 years of age weighing ≥ 14 to \< 25 kg) will receive E/C/F/TAF (90/90/120/6 mg) FDC once daily for 48 weeks. Participants who attain a weight of ≥ 25 kg during the course of the study will switch to adult E/C/F/TAF (150/150/200/10 mg) tablets. Participants who complete 48 weeks of study treatment will have the option to receive E/C/F/TAF in an extension phase of the study until: a) the participant turns 18 years old and E/C/F/TAF is commercially available for adults in the country in which the participant is enrolled; b) age-appropriate E/C/F/TAF became commercially available in the country in which the participant is enrolled; or c) Gilead elects to terminate development of E/C/F/TAF in that country.

Group II: Cohort 2: Age 6 to < 12 Years and Weight ≥ 25 kgExperimental Treatment1 Intervention

Virologically suppressed HIV-infected children (6 to \< 12 years of age weighing ≥ 25 kg) will receive E/C/F/TAF (150/150/200/10 mg) FDC once daily for 48 weeks. Participants who complete 48 weeks of study treatment will have the option to receive E/C/F/TAF in an extension phase of the study until: a) the participant turns 18 years old and E/C/F/TAF is commercially available for adults in the country in which the participant is enrolled; b) age-appropriate E/C/F/TAF become commercially available in the country in which the participant is enrolled; or c) Gilead elects to terminate development of E/C/F/TAF in that country.

Group III: Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kgExperimental Treatment1 Intervention

HIV-infected, ARV treatment-naive adolescents (12 to \< 18 years of age weighing ≥ 35 kg) will receive E/C/F/TAF (150/150/200/10 mg) fixed-dose combination (FDC) once daily for 48 weeks. Participants who complete 48 weeks of study treatment will have the option to receive E/C/F/TAF in an extension phase of the study until: a) the participant turns 18 years old and E/C/F/TAF is commercially available for adults in the country in which the participant is enrolled; b) age-appropriate E/C/F/TAF become commercially available in the country in which the participant is enrolled; or c) Gilead elects to terminate development of E/C/F/TAF in that country.