A MULTI-CENTER, OPEN LABEL, EXPANDED ACCESS TRIAL OF MARAVIROC

Phase 3

Completed

Conditions: AIDS
CCR5 HIV
10047438

Registration Number: NL-OMON31084

Lead Sponsor: Pfizer

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 15

Inclusion Criteria

- subjects must be failing on adequate virologic suppression: HIV-1 RNA > 1000 copies/ml
- R5 HIV-1 at screening as verified by Monogram Biosciences Trofile assay

Exclusion Criteria

- potentially life threatening lab abnormalities or medical condition still under investigation felt not to affect risk/benefit assessment of safety results.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Safety data will be categorically summarized: Proportion of subjects with Grade<br /><br>3 and 4 AEs, SAEs, and laboratory abnormalities (overall and according to<br /><br>investigator assigned causality). Possible AIDS-related infections and<br /><br>diseases will be summarized. Possible AIDS-related infections/events will also<br /><br>be summarized in their entirety, by baseline viral load, by baseline/nadir CD4<br /><br>cell counts and by time on therapy. Safety by gender, race, age and baseline<br /><br>HBV and/or HCV serology will also be summarized.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary Endpoints include the following and will be descriptive in nature.<br /><br>•Viral response<br /><br>•The change in CD4 count<br /><br>•The emergence/unmasking of CXCR4 using virus between screening (baseline) and<br /><br>time of virologic failure will be assessed.</p><br>