Text Size

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This study has been withdrawn prior to enrollment.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
History of Changes
  Purpose

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.


Condition Intervention Phase
Human Immunodeficiency Virus
 Drug: CP-675,206
 Phase 2

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

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Further study details as provided by Pfizer:

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

Estimated Enrollment: 32
Study Start Date: July 2007
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00488995

Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
To obtain contact information for a study center near you, click here.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00488995     History of Changes
Other Study ID Numbers: A3671029
Study First Received: June 19, 2007
Last Updated: April 2, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
HIV Therapeutic Vaccine

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immunologic Deficiency Syndromes
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
 Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on May 23, 2013