Study To Evaluate Emtricitabine/Tenofovir Alafenamide (F/TAF) in Human Immunodeficiency Virus 1 (HIV-1) Infected Children and Adolescents Virologically Suppressed on a 2- Nucleoside/Nucleotide Reverse Transcriptase Inhibitor (2-NRTI)-Containing Regi

• Status: Active, not recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective of this study is to confirm the TAF dose and to evaluate the pharmacokinetics (PK) of TAF, safety, and tolerability of F/TAF in HIV-1 infected children and adolescents virologically suppressed (defined as having < 50 copies/mL of HIV-1 ribonucleic acid [RNA] for a period of at least 6 months) while on a stable NRTI containing regimen.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gilead Sciences
• Treatments: Emtricitabine; Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; Tenofovir

Criteria

Key Inclusion Criteria:

• HIV-1 infected male and female adolescents and children aged 1 month to < 18 years at baseline/Day 1 (according to requirements of the enrolling cohort)

• Must be able to give written assent prior to any screening evaluations

• Parent or guardian able to give written informed consent prior to any screening evaluations and willing to comply with study requirements

• Body weight at screening as follows:

• Cohort 1: ≥ 35 kg

• Cohort 2, Group 1: ≥ 25 kg

• Cohort 2, Group 2: 17 kg to < 25 kg

• Cohort 3: to be updated per a protocol amendment

• Cohort 4: to be updated per a protocol amendment

• Currently on a stable 2-NRTI containing regimen that includes a 3rd ARV agent for ≥ 6 consecutive months prior to screening

• Plasma HIV-1 RNA levels < 50 copies/mL for ≥ 6 consecutive months preceding the screening visit

• No opportunistic infection within 30 days of study entry (at baseline/Day 1)

• A negative serum β-human chorionic gonadotropin (HCG) pregnancy test is required for females of childbearing potential only

Key Exclusion Criteria:

• An acquired immunodeficiency syndrome (AIDS) - indicator condition with onset within 30 days prior to screening

• Life expectancy of < 2 years

• Active, serious infections (other than HIV-1 infection) requiring parenteral antibiotic or antifungal therapy within 30 days prior to baseline/Day 1

• Evidence of active pulmonary or extra-pulmonary tuberculosis disease within 3 months of the screening visit

• Active hepatitis C virus (HCV) infection defined as positive for HCV antibody and having detectable HCV RNA

• Positive hepatitis B surface antigen or other evidence of active hepatitis B virus (HBV) infection.

• Have any serious or active medical or psychiatric illness which, in the opinion of the Investigator, would interfere with treatment, assessment, or compliance with the protocol.

• Pregnant or lactating females

• Have history of significant drug sensitivity or drug allergy

• Have previously participated in an investigational trial involving administration of any investigational agent, other than tenofovir, within 30 days prior to the study dosing

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