CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,047 enrolled
Drug / intervention
maravirocdrug
Likely dose
Maraviroc 300 mg twice daily (adjusted to 150 mg twice daily if used with CYP3A4 inhibitor)AI-extracted
Key inclusion· 3
  • ✓HIV-1 RNA ≥1000 copies/mL at screening, indicating virologic failure on current regimen
  • ✓R5-tropic HIV-1 confirmed by Monogram Biosciences Trofile assay
  • ✓Age ≥16 years or minimum adult age per local regulatory authority
Key exclusion· 2
  • ✕Prior treatment with any CCR5 antagonist
  • ✕Prior premature discontinuation of maraviroc in trials

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

Search/NCT00426660
NCT00426660Phase 3Completed
CompareCT.gov

A Multicenter, Open Label, Expanded Access Trial Of Maraviroc

ViiV Healthcare·interventional·Posted Jan 25, 2007·Updated Jun 29, 2016

In Brief

A Phase 3 clinical trial evaluating maraviroc for HIV Infections. Completed, enrolled 1,047 participants across 361 sites in 26 countries.

Detailed Summary

To provide access to maraviroc to patients who have limited or no therapeutic treatment options and to collect more safety data in a broader patient population.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV Infections
CountriesArgentina, Australia, Austria, Belgium, Canada, Chile, Costa Rica, Dominican Republic, France, Germany, Greece, Hong Kong, India, Ireland, Italy, Malaysia, Mexico, Netherlands, Portugal, Puerto Rico, Romania, Spain, Switzerland, Taiwan, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 25, 2007
Enrollment StartFeb 1, 2007
Primary CompletionJun 1, 2010
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 19.4 years ago

Interventions

maravirocdrug

The nominal dose for maraviroc is 300 mg twice a day (BID). However, the dosage of maraviroc should be adjusted based on optimal background therapy (OBT) patient is taking. If OBT includes CYP3A4 inhibitor (with or without inducers) maraviroc dose should be 150 mg BID and if OBT includes CYP3A4 inducer (without inhibitors) maraviroc dose should be 600mg BID. If OBT does not include any CYP3A4 inducers or inhibitors maraviroc dose should be 300 mg BID.