Pharmacokinetics, Safety, and Efficacy of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Disoproxil Fumarate Single Tablet Regimen (STR) in Adolescents
Completed · Phase 2/Phase 3
Conditions studied: Acquired Immunodeficiency Syndrome, HIV Infections
In brief
The primary objectives of this study are to evaluate the steady-state pharmacokinetics (PK) and confirm the dose of the elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (EVG/COBI/FTC/TDF) single-tablet regimen (STR) (Part A) and to evaluate the safety and tolerability of EVG/COBI/FTC/TDF STR through Week 48 (Part B) in HIV-1 infected, antiretroviral (ARV) treatment-naive adolescents. A total of 50 adolescent participants (12 to \< 18 years of age) will be enrolled to receive EVG/COBI/FTC/TDF as follows: * Part A: Twelve to 16 eligible participants will be enrolled to evaluate steady-state PK, and confirm the dose, with the intent to enroll at least 4 participants 12 to \< 15 and at least 4 participants 15 to \< 18 years of age. * Part B: Following confirmation of EVG exposure in at least 12 participants from Part A, 34 to 38 participants in addition to those enrolled in Part A will be enrolled to evaluate the safety, tolerability, and antiviral activity of EVG/COBI/FTC/TDF STR.
Key facts
- Study ID
- NCT01721109
- Run by
- Gilead Sciences
- People needed
- 50
- Starts
- 2012-12-06
- Expected to finish
- 2018-01-29
- Last updated by the study team
- 2018-08-17
Who can join
Age: 12 and older, up to 17. Sex: any. Healthy volunteers: not accepted.
Where it is running
- East Bay AIDS Center Medical Group — Oakland, California, United States
- University of South Florida - Department of Pediatrics — Tampa, Florida, United States
- University of Chicago — Chicago, Illinois, United States
- New York University School of Medicine — New York, New York, United States
- Montefiore Medical Center — The Bronx, New York, United States
- St. Christopher's Hospital for Children — Philadelphia, Pennsylvania, United States
- St. Jude Children's Research Hospital — Memphis, Tennessee, United States
- Rahima Moosa Mother and Child Hospital (Wits) — Johannesburg, Gauteng, South Africa
- Dr Latiff Private Practice — Durban, KwaZulu-Natal, South Africa
- Desmond Tutu HIV Research Centre — Cape Town, South Africa
- Mpati Medical Center — Dundee, South Africa
- Clinical HIV Research Unit — Johannesburg, South Africa
- Perinatal HIV Research Unit — Soweto, South Africa
- University of Stellenbosch — Stellenbosch, South Africa
- The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT) — Bangkok, Thailand
- Siriraj Hospital, Mahidol University — Bangkok, Thailand
- Queen Savang Vadhana Memorial Hospital — Chon Buri, Thailand
- Srinakarind Hospital — Khon Kaen, Thailand
Full record on ClinicalTrials.gov
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