Study Details

OVERVIEW

A Phase 2/3, Open-Label Study of the Pharmacokinetics, Safety, and Antiviral Activity of the Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (E/C/F/TAF) Single Tablet Regimen (STR) in HIV-1 Infected Antiretroviral Treatment-Naive Adolescents and Virologically Suppressed Children

PROTOCOL SUMMARY

The primary objectives of Cohort 1 are to evaluate the steady state pharmacokinetics (PK) for elvitegravir (EVG) and tenofovir alafenamide (TAF) and confirm the dose of the elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) STR (Part A) and to evaluate the safety and tolerability of E/C/F/TAF STR through Week 24 (Part B) in human immunodeficiency virus - 1 (HIV-1) infected, antiretroviral (ARV) treatment-naive adolescents. The primary objectives of Cohort 2 are to evaluate the PK of EVG and TAF in virologically suppressed HIV-1 infected children 6 to < 12 years of age weighing ≥ 25 kg administered E/C/F/TAF STR (Part A) and to evaluate the safety and tolerability of E/C/F/TAF STR through Week 24 in virologically suppressed HIV-1 infected children 6 to < 12 years of age weighing ≥ 25 kg (Part B). The primary objectives of Cohort 3 are to evaluate the PK of EVG and TAF and confirm the dose of the STR, and to evaluate the safety and tolerability of E/C/F/TAF low dose (LD) STR in virologically suppressed HIV-1 infected children ≥ 2 years of age and weighing ≥ 14 to < 25 kg.

Participation Requirements

Age

2 Years - 17 Years

Sex

All

Healthy Volunteers

Medical Condition

Acquired Immune Deficiency Syndrome (AIDS), HIV Infections

Gender

N/A

Date

May 2013 - May 2020

Study Type

Interventional

Study Phase

Phase 2, Phase 3

Product

E/C/F/TAF, E/C/F/TAF (Low Dose)

Eligibility Information

Inclusion Criteria

Cohort 1
12 years to < 18 years of age at baseline
Weight greater than or equal to 35 kg (77 lbs)
Plasma HIV-1 ribonucleic acid (RNA) levels of ≥ 1,000 copies/mL at screening (Roche COBAS TaqMan v2.0)
Screening genotype report shows sensitivity to EVG, FTC and tenofovir (TFV)
No prior use of any approved or experimental anti-HIV-1 drug for any length of time
Cohort 2
6 years to < 12 years of age at baseline
Weight greater than or equal to 25 kg (55 lbs)
Plasma HIV-1 RNA of < 50 copies/mL (or undetectable HIV-1 RNA level according to the local assay being used if the limit of detection is > 50 copies/mL) for ≥ 180 consecutive days (6 months) prior to screening on a stable antiretroviral regimen, without documented history of resistance to any component of E/C/F/TAF STR.
Cohort 3
Age at baseline: ≥ 2 years old
Weight at screening: ≥ 14 kg (31 lbs) to < 25 kg (55 lbs)
Plasma HIV-1 RNA: < 50 copies/mL (or undetectable HIV-1 RNA level according to the local assay being used if the limit of detection is > 50 copies/mL) for ≥ 180 consecutive days (6 months) prior to screening on a stable antiretroviral regimen, without prior history of resistance to any component of E/C/F/TAF STR

Exclusion Criteria

Hepatitis B or hepatitis C virus infection
Evidence of active pulmonary or extra-pulmonary tuberculosis disease within 3 months of the screening visit.
Individuals experiencing decompensated cirrhosis
Pregnant or lactating females
Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Locations

Locations (16)

Miller's Children Hospital

Long Beach, California, United States, 90806

Children's Research Institute

Washington, District of Columbia, United States, 20010

Emory University School of Medicine

Atlanta, Georgia, United States, 30322

St. Jude Children's Research Hospital

Memphis, Tennessee, United States, 38105

Seattle Children's Hospital

Seattle, Washington, United States, 98105-0371

KIDCRU Ward J8

Cape Town, South Africa, 7505

Be Part Yoluntu Centre

Cape Town, South Africa, 7646

Desmond Tutu HIV Foundation

Cape Town, South Africa, 7705

Perinatal HIV Research Unit Baragwanath Hospital

Johannesburg, South Africa, 1862

Clinical HIV Research Unit

Johannesburg, South Africa, 2041

Empilweni Services and Research Unit (ESRU)

Johannesburg, South Africa, 2092

The HIV Netherlands Australia Thailand Research collaboration (HIV-NAT)

Bangkok, Thailand, 10330

Queen Savang Vadhana Memorial Hospital

Chon Buri, Thailand, 20110

Department of Pediatrics, Faculty of Medicine, Khon Kaen University

Khon Kaen, Thailand, 40002

Joint Clinical Research Centre

Kampala, Uganda, PO Box 10005

University of Zimbabwe - Clinical Research Centre

Belgravia, Zimbabwe, 263

Study to Evaluate the Pharmacokinetics, Safety, and Antiviral Activity of the Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (E/C/F/TAF) Single Tablet Regimen (STR) in HIV-1 Infected Antiretroviral Treatment-Naive Adolescents and Virologically Suppressed Children