Maraviroc Compassionate Use

• Status: Withdrawn
• Trial end date: 2010-05-01
• Target enrollment: 0
• Participant gender: All

Summary

The objective of this study is to provide Maraviroc on a compassionate use basis to antiretroviral treatment experienced patients infected with CCR5-tropic HIV-1 with urgent unmet medical needs and who, in the opinion of the physician, require Maraviroc to form a viable regimen.

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

Details

• Lead Sponsor: ViiV Healthcare
• Collaborator: Pfizer
• Treatments: Maraviroc

Criteria

Inclusion Criteria:

• Patients at least 16 years old with prior extensive treatment experience with limited further options in need of maraviroc to constitute an effective HIV-1 treatment regimen.

• Have only CCR5-tropic HIV-1 virus

• CD4+ cell count < 200 cells/mm3

Exclusion Criteria:

• CXCR4- or dual/mixed-tropic HIV-1 virus

• Patients who in the opinion of investigator are unlikely to derive benefit from maraviroc as a result of severity of illness

• Patients who are pregnant or breast feeding an infant or planning to become pregnant.