At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 47 enrolled
Drug / intervention
Maraviroc +1 moredrug
Likely dose
Maraviroc 8 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase I Safety and Pharmacokinetic Study of Maraviroc in HIV-1-Exposed Infants at Risk of Acquiring HIV-1 Infection
National Institute of Allergy and Infectious Diseases (NIAID)·interventional·Posted May 19, 2016·Updated Jan 4, 2022
In Brief
A Phase 1 clinical trial evaluating Maraviroc for HIV Infections. Completed, enrolled 47 participants across 9 sites in 4 countries.
Detailed Summary
This study aimed to evaluate the safety, tolerability, and pharmacokinetics of maraviroc in infants at risk for mother-to-child HIV transmission, and to determine an appropriate dose of maraviroc during the first six weeks of life.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV Infections
CountriesKenya, South Africa, Thailand, United States
Timeline
Phase 1CompletedFinished
2017201820192020202120222023202420252026
First PostedMay 2016
Enrollment StartJun 2017
Primary CompletionSep 2019
Study CompletionNov 2019
TodayJul 2026
First PostedMay 19, 2016
Enrollment StartJun 5, 2017
Primary CompletionSep 6, 2019
Study CompletionNov 20, 2019
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 10.1 years ago
Interventions
Maravirocdrug
8 mg/kg oral solution as a single dose.
Maravirocdrug
8 mg/kg oral solution given twice daily.