AIDS CCR5 HIV
Conditions
Interventions
Maraviroc therapy
Sponsors
Pfizer
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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
Exclusion criteria: - potentially life threatening lab abnormalities or medical condition still under investigation felt not to affect risk/benefit assessment of safety results.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety data will be categorically summarized: Proportion of subjects with Grade 3 and 4 AEs, SAEs, and laboratory abnormalities (overall and according to investigator assigned causality). Possible AIDS-related infections and diseases will be summarized. Possible AIDS-related infections/events will also be summarized in their entirety, by baseline viral load, by baseline/nadir CD4 cell counts and by time on therapy. Safety by gender, race, age and baseline HBV and/or HCV serology will also be summarized. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Endpoints include the following and will be descriptive in nature. •Viral response •The change in CD4 count •The emergence/unmasking of CXCR4 using virus between screening (baseline) and time of virologic failure will be assessed. | — |
Countries
Netherlands
Outcome results
None listed