Safety And Efficacy Study Of CP-675,206 In HIV-Infected Patients
Phase 2
Withdrawn
- Conditions
- Human Immunodeficiency Virus
- Registration Number
- NCT00488995
- Lead Sponsor
- Pfizer
- Brief Summary
The purpose of this study is to determine if CP-675,206, a monoclonal antibody to CTLA4, is safe and well-tolerated, reduces viral load, and improves immune function in patients infected with HIV.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
- HIV infected man or woman at least 18 years of age who is available for a follow up period of at least 3 months
- Has been on a stable antiretroviral regimen for ≥3 months and willing to remain on current antiretroviral regimen for an additional 3 months or has been off of antiretroviral therapy for at least 8 weeks and willing to remain off of antiretroviral therapy for another 3 months
- Plasma HIV 1 RNA ≥5,000 copies/mL measured by Roche Amplicor HIV 1 Monitor at the screening visit
- CD4 T-cells ≥200 cells/mm3
Exclusion Criteria
- History of, or significant evidence of risk for, chronic inflammatory or autoimmunedisease (eg, Addison's disease, asthma, celiac disease, multiple sclerosis, Graves disease, Hashimoto's thyroiditis, inflammatory bowel disease, psoriasis, rheumatoid arthritis, systemic lupus erythematosus, etc)
- History of inflammatory bowel disease (eg, Crohn's disease or ulcerative colitis), celiac disease, or other chronic gastrointestinal conditions associated with diarrhea, or current acute colitis of any origin, and any history of diverticulitis (even a single episode) or evidence of diverticulitis at baseline, including evidence limited to CT-scan only
- Exposure within the previous 3 months to a drug known to have immunomodulatory effects (eg, IL 2)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Maximum reduction in HIV plasma RNA between Baseline and Week 12 Maximum increase in CD4+ cell count between Baseline and Week 12
- Secondary Outcome Measures
Name Time Method Change from baseline in CD8+ cell count, CD4/CD8, and lymphocyte phenotype through Week 12