Safety And Efficacy Study Of CP-675,206 In HIV-Infected Patients
Primary Purpose
Human Immunodeficiency Virus
Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
CP-675,206
Sponsored by
About this trial
This is an interventional treatment trial for Human Immunodeficiency Virus focused on measuring HIV Therapeutic Vaccine
Eligibility Criteria
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)
Sites / Locations
Outcomes
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00488995
Brief Title
Safety And Efficacy Study Of CP-675,206 In HIV-Infected Patients
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 Type
Interventional
2. Study Status
Record Verification Date
March 2015
Overall Recruitment Status
Withdrawn
Study Start Date
July 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Pfizer
4. Oversight
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Human Immunodeficiency Virus
Keywords
HIV Therapeutic Vaccine
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
Single
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
CP-675,206
Primary Outcome Measure Information:
Title
Maximum reduction in HIV plasma RNA between Baseline and Week 12 Maximum increase in CD4+ cell count between Baseline and Week 12
Secondary Outcome Measure Information:
Title
Change from baseline in CD8+ cell count, CD4/CD8, and lymphocyte phenotype through Week 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
12. IPD Sharing Statement
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A3671029&StudyName=Safety+And+Efficacy+Study+Of+CP%2D675%2C206+In+HIV%2DInfected+Patients
Description
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Safety And Efficacy Study Of CP-675,206 In HIV-Infected Patients
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