NCT00488995

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.

Trial Health

10
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 19, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 20, 2007

Completed
11 days until next milestone

Study Start

First participant enrolled

July 1, 2007

Completed
Last Updated

March 11, 2015

Status Verified

March 1, 2015

First QC Date

June 19, 2007

Last Update Submit

March 10, 2015

Conditions

Human Immunodeficiency Virus

Keywords

HIV Therapeutic Vaccine

Outcome Measures

Primary Outcomes (1)

  • Maximum reduction in HIV plasma RNA between Baseline and Week 12 Maximum increase in CD4+ cell count between Baseline and Week 12

Secondary Outcomes (1)

  • Change from baseline in CD8+ cell count, CD4/CD8, and lymphocyte phenotype through Week 12

Interventions

CP-675,206DRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Interventions

tremelimumab

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

June 19, 2007

First Posted

June 20, 2007

Study Start

July 1, 2007

Last Updated

March 11, 2015

Record last verified: 2015-03