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

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00488995
First received: June 19, 2007
Last updated: April 2, 2008
Last verified: April 2008

June 19, 2007
April 2, 2008
July 2007
Not Provided
Maximum reduction in HIV plasma RNA between Baseline and Week 12 Maximum increase in CD4+ cell count between Baseline and Week 12
Same as current
Complete list of historical versions of study NCT00488995 on ClinicalTrials.gov Archive Site
Change from baseline in CD8+ cell count, CD4/CD8, and lymphocyte phenotype through Week 12
Same as current
Not Provided
Not Provided
 
Safety And Efficacy Study Of CP-675,206 In HIV-Infected Patients
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

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind
Primary Purpose: Treatment
Human Immunodeficiency Virus
Drug: CP-675,206
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
32
Not Provided
Not Provided

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)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00488995
A3671029
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
April 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP