Status:
COMPLETED
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
Lead Sponsor:
Gilead Sciences
Conditions:
HIV-1
Eligibility:
All Genders
1-17 years
Phase:
PHASE2
PHASE3
Brief 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 children and adolescents with HIV-1 who are virolo...
Detailed Description
A minimum of 100 participants in total (across all cohorts) aged 1 month to \<18 years of age will be enrolled to receive F/TAF. The study will proceed in sequential cohorts as follows: Cohort 1 will ...
Eligibility Criteria
Inclusion
- Key
- Human immunodeficiency virus 1 (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-nucleoside/nucleotide reverse transcriptase inhibitor (NRTI) containing regimen that includes a 3rd antiretroviral (ARV) agent for ≥ 6 consecutive months prior to screening
- Plasma HIV-1 ribonucleic acid (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
- 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 TDF, within 30 days prior to the study dosing
- NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.
Key Trial Info
Start Date :
January 20 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 11 2024
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT02285114
Start Date
January 20 2015
End Date
December 11 2024
Last Update
June 27 2025
Active Locations (8)
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1
University of California Los Angeles
Los Angeles, California, United States, 90095
2
Children's Hospital Colorado
Aurora, Colorado, United States, 80045
3
St. Christopher's Hospital for Children
Philadelphia, Pennsylvania, United States, 19134
4
Seattle Children's Hospital
Seattle, Washington, United States, 98105-0371