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

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NCT00488995

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FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

By phone

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1-800-718-1021

By email

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[email protected]

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Human Immunodeficiency Virus
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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)

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Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

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Advanced Information
Descriptive Information
Brief Title  ICMJE Safety And Efficacy Study Of CP-675,206 In HIV-Infected Patients
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single
Primary Purpose: Treatment
Condition  ICMJE Human Immunodeficiency Virus
Intervention  ICMJE Drug: CP-675,206
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: March 10, 2015)		0
Original Enrollment  ICMJE
 (submitted: June 19, 2007)		32
Study Completion Date  ICMJE Not Provided
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00488995
Other Study ID Numbers  ICMJE A3671029
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date March 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP