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

Sponsor

Pfizer (Industry)

Overall Status

Withdrawn

CT.gov ID

NCT00488995

Collaborator

(none)

Enrollment

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Human Immunodeficiency Virus	Drug: CP-675,206	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

Single

Primary Purpose:

Treatment

Official Title:

A Phase 2 Study To Evaluate The Safety, Tolerability, Virologic And Immunologic Effect Of Single-Dose CP-675,206 In Patients Infected With Human Immunodeficiency Virus

Study Start Date :

Jul 1, 2007

Outcome Measures

Primary Outcome Measures

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

Change from baseline in CD8+ cell count, CD4/CD8, and lymphocyte phenotype through Week 12 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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)