Study Details

PROTOCOL 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.

Participation Requirements

Age

1 Month - 17 Years

Sex

All

Healthy Volunteers

Medical Condition

HIV-1

Gender

N/A

Date

January 2015 - November 2019

Study Type

Interventional

Study Phase

Phase 2, Phase 3

Product

F/TAF, 3rd ARV agent, Boosted PIs

Eligibility Information

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

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.

Locations

Locations (8)

University of California Los Angeles

Los Angeles, California, United States, 90095

Children's Hospital Colorado

Aurora, Colorado, United States, 80045

St. Christopher's Hospital for Children

Philadelphia, Pennsylvania, United States, 19134

Seattle Children's Hospital

Seattle, Washington, United States, 98105-0371

Hospital del Nino

Panama City, Panama, 0816-00383

Rahima Moosa Mother and Child Hospital

Johannesburg, Coronationville, South Africa, 2093

KIDCRU, Ward J8, Tygerberg Children's Hospital

Cape Town, South Africa, 7505

Be Part Yoluntu Centre

Cape Town, South Africa, 7626

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 Regimen

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