Expanded Access Program for Maraviroc At Multiple Centers

• Status: Completed
• Trial end date: 2010-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: ViiV Healthcare
• Treatments: Maraviroc

Criteria

Inclusion Criteria:

• Subjects must be failing to achieve adequate virologic suppression on their current regimen and have HIV-1 RNA greater than or equal to 1000 copies/ml, at screening

• Have only R5 HIV-1 at Screening as verified by the Monogram Biosciences Trofile assay

• Minimum age must be 16 years or minimum adult age as determined by local regulatory authorities or directed by local law.

Exclusion Criteria:

• Failed prior treatment with any CCR5 antagonist, in any ongoing CCR5 trial or having previously prematurely discontinued Maraviroc in trials