Safety And Efficacy Study Of CP-675,206 In HIV-Infected Patients
NCT00488995
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
- 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
- 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)
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Descriptive Information | ||||
---|---|---|---|---|
Brief Title ICMJE | Safety And Efficacy Study Of CP-675,206 In HIV-Infected Patients | |||
Official Title ICMJE | 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 | |||
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 Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 2 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Single Group Assignment Masking: Single Primary Purpose: Treatment | |||
Condition ICMJE | Human Immunodeficiency Virus | |||
Intervention ICMJE | Drug: CP-675,206 | |||
Study Arms ICMJE | Not Provided | |||
Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Withdrawn | |||
Actual Enrollment ICMJE | 0 | |||
Original Enrollment ICMJE | 32 | |||
Study Completion Date ICMJE | Not Provided | |||
Primary Completion Date | Not Provided | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
Sex/Gender ICMJE |
| |||
Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Not Provided | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00488995 | |||
Other Study ID Numbers ICMJE | A3671029 | |||
Has Data Monitoring Committee | Not Provided | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Director, Clinical Trial Disclosure Group, Pfizer, Inc. | |||
Study Sponsor ICMJE | Pfizer | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
| |||
PRS Account | Pfizer | |||
Verification Date | March 2015 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |