Status:
COMPLETED
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
Lead Sponsor:
Gilead Sciences
Conditions:
Acquired Immune Deficiency Syndrome (AIDS)
HIV Infections
Eligibility:
All Genders
2-17 years
Phase:
PHASE2
PHASE3
Brief 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/emt...
Eligibility Criteria
Inclusion
- Key
- Cohort 1
- Age at baseline: 12 years to \< 18 years old
- Weight at screening: ≥ 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, emtricitabine (FTC) and tenofovir (TFV)
- No prior use of any approved or experimental anti-HIV-1 drug for any length of time
- Cohort 2
- Age at baseline: 6 years to \< 12 years old
- Weight at screening: ≥ 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
- Key
Exclusion
- 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.
Key Trial Info
Start Date :
May 6 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 18 2025
Estimated Enrollment :
129 Patients enrolled
Trial Details
Trial ID
NCT01854775
Start Date
May 6 2013
End Date
June 18 2025
Last Update
January 9 2026
Active Locations (16)
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1
Miller's Children Hospital
Long Beach, California, United States, 90806
2
Children's Research Institute
Washington D.C., District of Columbia, United States, 20010
3
Emory University School of Medicine
Atlanta, Georgia, United States, 30322
4
St. Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105