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

Human Immunodeficiency Virus Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00488995
• Other study ID #: A3671029
• Status: Withdrawn
• Phase: Phase 2
• First received: June 19, 2007
• Last updated: March 10, 2015
• Start date: July 2007

Study information

• Verified date: March 2015
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• Human Immunodeficiency Virus
• Immunologic Deficiency Syndromes

Intervention

Drug:
• CP-675,206

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum reduction in HIV plasma RNA between Baseline and Week 12 Maximum increase in CD4+ cell count between Baseline and Week 12
Secondary	Change from baseline in CD8+ cell count, CD4/CD8, and lymphocyte phenotype through Week 12

External Links

•   To obtain contact information for a study center near you, click here.