At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 138 enrolled
Drug / intervention
Maraviroc +1 moredrug
Likely dose
Maraviroc 150mgfrom 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.
A Multicenter, Randomized, Blinded, Placebo-controlled Study To Evaluate The Safety Of Maraviroc In Combination With Other Antiretroviral Agents In Hiv-1-infected Subjects Co-infected With Hepatitis C And/or Hepatitis B Virus
In Brief
A Phase 4 clinical trial evaluating Maraviroc and Placebo for HIV Coinfection. Completed, enrolled 138 participants across 48 sites in 9 countries.
Detailed Summary
To describe liver enzyme elevations in patients who are coinfected with HIV and either Hepatitis C (HCV) and/or Hepatitis B (HBV) receiving maraviroc or placebo in combination with their current suppressive anti-HIV drug therapy.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV Coinfection
CountriesCzechia, France, Germany, Hungary, Poland, Puerto Rico, Spain, United Kingdom, United States
CollaboratorsPfizer
Timeline
Phase 4CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedApr 2011
Enrollment StartMay 2011
Primary CompletionApr 2013
Study CompletionMar 2015
TodayJul 2026
First PostedApr 1, 2011
Enrollment StartMay 18, 2011
Primary CompletionApr 23, 2013
Study CompletionMar 24, 2015
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 15.3 years ago
Interventions
Maravirocdrug
150mg, 300mg or 600mg twice daily x 144 weeks; dosing dependent on components of the current suppressive anti-HIV therapy
Placebodrug
150mg, 300mg or 600mg twice daily x 144 weeks; dosing dependent on components of the current suppressive anti-HIV therapy