Safety And Efficacy Study Of CP-675,206 In HIV-Infected Patients

Pfizer

Status and phase

Withdrawn

Phase 2

Conditions

Human Immunodeficiency Virus

Treatments

Drug: CP-675,206

Study type

Interventional

Funder types

Industry

Identifiers

NCT00488995

A3671029

Details and patient eligibility

About

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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)