Back to results

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Withdrawn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

About this trial

This is an interventional treatment trial for Human Immunodeficiency Virus focused on measuring HIV Therapeutic Vaccine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

NCT ID

NCT00488995

First Posted

June 19, 2007

Last Updated

March 10, 2015

Sponsor

Pfizer

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

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

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

Learn more about this trial

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

We'll reach out to this number within 24 hrs