Two Part Study to Evaluate Pharmacokinetics, Safety, and Antiviral Activity of Elvitegravir Administered With a PI/r Background Regimen for ARV Treatment-Experienced Pediatric Participants
Stopped early · Phase 2/Phase 3
Conditions studied: Acquired Immune Deficiency Syndrome (AIDS), HIV Infections
In brief
The primary objectives of this study are to evaluate the safety, tolerability and steady-state PK and confirm the dose of EVG/r in HIV-1 infected, antiretroviral treatment-experienced children 4 weeks to \<18 years of age. The study consists of 2 parts: Part A and Part B. Part A will enroll participants with suppressed viremia (HIV-1 RNA \< 50 copies/mL) or failing a current antiretroviral (ARV) regimen (HIV-1 RNA \> 1,000 copies/mL only for participants in Cohort 2, Part A) to evaluate the steady state PK and confirm the dose of EVG. Part B will enroll participants who are failing a current ARV regimen (HIV-1 RNA \> 1,000 copies/mL) to evaluate the safety, tolerability, and antiviral activity of EVG. The study consists of 4 age cohorts with each cohort including 2 parts (Part A and Part B) with the exception of the adolescent age cohort (Cohort 1: 12 to \< 18 years old) containing Part B only.
Key facts
- Study ID
- NCT01923311
- Run by
- Gilead Sciences
- People needed
- 31
- Starts
- 2013-08-26
- Expected to finish
- 2017-11-03
- Last updated by the study team
- 2018-08-09
Who can join
Age: 0 and older, up to 17. Sex: any. Healthy volunteers: not accepted.
Where it is running
- University of Colorado Denver — Aurora, Colorado, United States
- Duke University Medical Center — Durham, North Carolina, United States
- St. Jude Children's Research Hospital — Memphis, Tennessee, United States
- Universita degli Studi di Pavia - Fondazione IRCCS Policlinico San Matteo — Pavia, Italy
- Be Part Yoluntu Centre — Cape Town, South Africa
- Rahima Moosa Mother and Child Hopsital — Johannesburg, South Africa
- Hospital Universitario De Getafe — Getafe, Madrid, Spain
- Hospital 12 de Octubre — Madrid, Spain
- Thai Red Cross AIDS Research Centre (HIV-NAT) — Bangkok, Thailand
- Siriraj Hospital — Bangkok, Thailand
- Joint Clinical Research Centre — Kampala, Uganda
Full record on ClinicalTrials.gov
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