Study Details

OVERVIEW

A Phase 2/3, Open-Label Study of the Pharmacokinetics, Safety, and Antiviral Activity of the GS-9883/Emtricitabine/Tenofovir Alafenamide (GS-9883/F/TAF) Fixed Dose Combination (FDC) in HIV-1 Infected Adolescents and Children

PROTOCOL SUMMARY

The goals of this clinical study are to learn how Bictegravir/Emtricitabine/Tenofovir Alafenamide fixed dose combination (FDC) interacts with the body, confirm the dose, and also to learn more about the safety and tolerability of Bictegravir/Emtricitabine/Tenofovir Alafenamide FDC in adolescents and children with HIV-1.

Participation Requirements

Age

1 Month - 17 Years

Sex

ALL

Healthy Volunteers

Medical Condition

HIV-1 Infection

Gender

N/A

Date

September 2016 - March 2025

Study Type

INTERVENTIONAL

Study Phase

PHASE2, PHASE3

Product

B/F/TAF (Adult Strength), B/F/TAF (Low Dose), B/F/TAF (TOS), B/F/TAF (TOS), B/F/TAF (TOS), B/F/TAF (TOS)

Eligibility Information

Inclusion Criteria

Cohort 1: HIV-1 infected adolescents (12 to < 18 years of age and screening weight ≥ 35 kg) who are virologically suppressed for ≥ 6 months prior to screening. Cohort 2: HIV-1 infected children (6 to < 12 years of age and screening weight ≥ 25 kg) who are virologically suppressed for ≥ 6 months prior to screening.
Cohort 3: HIV-1 infected children (≥ 2 years of age and screening weight of ≥ 14 to < 25 kg) who are virologically suppressed for ≥ 6 months prior to screening.
Cohort 4 Group 1: HIV-1 infected children (≥ 2 years of age and screening weight of ≥ 14 to < 25 kg) who are virologically suppressed for ≥ 6 months prior to screening and unable to swallow tablets.
Documented plasma HIV-1 ribonucleic acid (RNA) < 50 copies/mL on a stable regimen (or undetectable HIV-1 RNA level according to the local assay being used if the limit of detection is ≥ 50 copies/mL) for ≥ 6 months preceding the Screening visit. Unconfirmed virologic elevations of ≥ 50 copies/mL (transient detectable viremia, or "blip") prior to screening are acceptable. If the lower limit of detection of the local HIV-1 RNA assay is < 50 copies/mL (eg, < 20 copies/mL), the plasma HIV-1 RNA level cannot exceed 50 copies/mL on two consecutive HIV-1 RNA tests.
Stable antiretroviral regimen of 2 nucleoside reverse transcriptase inhibitors (NRTIs) in combination with a third agent for a minimum of 6 months prior to the screening visit. Individuals undergoing dose modifications to their antiretroviral regimen for growth or who are switching medication formulation(s) are considered to be on a stable antiretroviral regimen.
Estimated glomerular filtration rate (eGFR) ≥ 90 mL/min/1.73 m^2 according to the Schwartz Formula.
No documented or suspected resistance to emtricitabine (FTC), tenofovir (TFV), or integrase strand transfer inhibitors (INSTIs) including, but not limited to, the reverse transcriptase resistance mutations K65R and M184V/I.
Cohort 4 Group 2-4: HIV-1 infected children (≥ 1 month of age and screening weight of ≥ 3 to < 14 kg) who are treatment naive or on antiretroviral (ARV) treatment for ≥ 1 month prior to screening.
Positive confirmatory HIV test (confirmatory nucleic acid-based testing if < 18 months of age).
On a stable ARV regimen for ≥ 1 month or treatment naive (Individual is considered treatment naive if ARVs were given for prevention of mother-to-child transmission but not for HIV treatment).
For < 1 year of age, eGFR ≥ the minimum normal values for age according to the information below using the Schwartz Formula,
30 mL/min/1.73 m^2 for age > 4 weeks to ≤ 95 days.
39 mL/min/1.73 m^2 for age ≥ 96 days to ≤ 6 months.
49 mL/min/1.73 m^2 for age > 6 months to < 12 months.
For ≥ 1 year of age, eGFR ≥ 90 mL/min/1.73 m^2 using the Schwartz Formula.
No documented or suspected resistance to FTC, TFV, or INSTIs including, but not limited to, the reverse transcriptase resistance mutation K65R.
For individuals < 14 kg, M184V/I AND HIV-1 RNA < 50 copies/mL will be allowed. Individuals with HIV-1 RNA > 50 copies/mL should not have FTC, TFV, or INSTI resistance mutations.
Last dose of nevirapine (NVP) or efavirenz (EFV), if applicable, ≥ 14 days prior to enrollment.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Exclusion Criteria

No Exclusion Criteria present

Locations

Locations (25)

Children's National Health System

Washington, District of Columbia, United States, 20010

Midway Immunology and Research Center

Fort Pierce, Florida, United States, 34982

University of Florida Health

Gainesville, Florida, United States, 32209

USF Clinic at Children's Medical Services (study visits and drug storage)

Tampa, Florida, United States, 33606

Grady Health System Ponce Center Family and Youth Clinic

Atlanta, Georgia, United States, 30322

Wayne Pediatric Clinic

Detroit, Michigan, United States, 48201

Bellevue Hospital

New York, New York, United States, 10016

Duke Children's Health Center, Pediatric Infectious Diseases

Durham, North Carolina, United States, 27710

St. Christopher's Hospital for Children/Section of Immunology

Philadelphia, Pennsylvania, United States, 19134

St. Jude Children's Research Hospital

Memphis, Tennessee, United States, 38105

Department of Paediatrics and Child Health

Bloemfontein, South Africa, 9301

Be Part Ypluntu Centre

Cape Town, South Africa, 7646

FAMCRU, Ward J8

CapeTown, South Africa, 7505

Dr. J Fourie Medical Centre

Dundee, South Africa, 3000

Enhancing Care Foundation, Durban International Clinical Research Site

Durban, South Africa, 4302

Wits RHI Shandukani Research Centre, Wits Reproductive Health & HIV Institute

Johannesburg, South Africa, 2038

Empilweni Service and Research Unit (ESRU)

Johannesburg, South Africa, 2112

VX Pharma(Pty) Ltd

Pretoria, South Africa, 0087

Perinatal HIV Research Unit

Soweto, South Africa, 2013

The HIV Netherlands Australia Thailand Research Collaboration

Bangkok, Thailand, 10330

Faculty of Medicine Siriraj Hospital, Mahidol University

Bangkok, Thailand, 10700

Faculty of Medicine, Khon Kaen University

Khon Kaen, Thailand, 40002

Makerere University, Johns Hopkins (MU-JHU) Research Collaboration

Kampala, Uganda, 0000

Joint Clinical Research Centre

Kampala, Uganda, 10005

Baylor College of Medicine Children's Foundation - Uganda

Kampala, Uganda

Study of Bictegravir/Emtricitabine/Tenofovir Alafenamide Fixed Dose Combination in Adolescents and Children With Human Immunodeficiency Virus-1