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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2007-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Human Immunodeficiency Virus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Interventions

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CP-675,206

Intervention Type DRUG

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No