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

Last updated on March 15, 2019

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Study Location
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Human Immunodeficiency Virus
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
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- 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)

NCT00488995
Pfizer
Withdrawn
Safety And Efficacy Study Of CP-675,206 In HIV-Infected Patients

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