CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 52 enrolled
Drug / intervention
Maraviroc +1 moredrug
Likely dose
Maraviroc 300 mg orally twice daily for 24 weeks (150 mg twice daily if on ritonavir)AI-extracted
Key inclusion· 3
  • Stable antiretroviral therapy for at least 12 months
  • Plasma HIV RNA < 50 copies/mL at screening, with all values in past year < 50 copies/mL (isolated single values 50-200 allowed)
  • ≥90% adherence to therapy in preceding 30 days by self-report
Key exclusion· 7
  • Prior or ongoing use of any integrase inhibitor or R5 inhibitor
  • Plan to modify existing antiretroviral therapy in next 24 weeks
  • Serious illness requiring hospitalization or parenteral antibiotics within preceding 3 months
  • Concurrent or recent exposure to immunomodulatory drugs

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00844519
NCT00844519Phase 3Completed

Effect of Maraviroc on Endothelial Function in HIV-Infected Patients

University of California, San Francisco·interventional·Posted Feb 16, 2009·Updated Jul 24, 2014

In Brief

A Phase 3 clinical trial evaluating Maraviroc and placebo for HIV Infection and 3 related conditions. Completed, enrolled 52 participants across 1 site.

Detailed Summary

The purpose of this study is to determine the potentially beneficial aspects of CCR5 inhibition on inflammation and endothelial function as measured by brachial artery reactivity in antiretroviral treated HIV patients with an undetectable viral load.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedFeb 16, 2009
Enrollment StartJan 1, 2010
Primary CompletionDec 1, 2012
Study CompletionJun 1, 2014
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 17.4 years ago

Interventions

Maravirocdrug

For subjects assigned to the maraviroc group, they will receive maraviroc at 300mg by mouth twice daily for 24 weeks in addition to taking their current anti-HIV medications. For subjects on ritonavir, the dose will be reduced to 150mg by mouth twice daily for 24 weeks.

placebodrug

For subjects assigned to the placebo group, they will receive a matching placebo pill 300mg to be taken by mouth twice daily for 24 weeks in addition to taking their current anti-HIV medications.