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Study Evaluating Vaccine in Adults With HIV

Last updated on November 13, 2019

FOR MORE INFORMATION
Study Location
Birmingham, Alabama, 35294 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
HIV Infections
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-50 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Must be HIV positive.

- Receiving stable HAART for a minimum of 6 consecutive months immediately before
screening.

- CD4 T-cell count greater than 350 mm cubed/mL at time of screening and no reported CD4
T-cell count less than 250 mm cubed/mL at any time before screening.

Other Inclusions Apply

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

- Any chronic symptomatic infection other than HIV.

- History of diagnosed autoimmune disease (currently active or under control).

- Use of any prior HIV vaccine (prophylactic and/or therapeutic) within one year before
or during screening (documented, unblinded placebo recipients from previous clinical
trials may participate without this time restriction).

Other Exclusions Apply

NCT00195312
Pfizer
Terminated
Study Evaluating Vaccine in Adults With HIV

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Descriptive Information
Brief Title  ICMJE Study Evaluating Vaccine in Adults With HIV
Official Title  ICMJE A Phase 1 Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Safety and Immunogenicity of an HIV-1 Gag DNA Vaccine Administered Alone or With Escalating Doses of IL-12 DNA or IL-15 DNA Molecular Adjuvants to HIV-1 Positive Adults Receiving Stable HAART.
Brief Summary

The main purpose of this study is to learn whether the study vaccine and the adjuvants(drugs that are used to help immune response) have an acceptable safety profile in treating individuals with HIV.

A second purpose for this study is to understand how your immune system responds to the study vaccine with the adjuvants. Understanding these differences could be useful in several ways. First, it might help identify people whose disease is likely to respond to the study vaccine with the study adjuvants. Second, the information might be useful in developing other treatments for people whose disease does not respond to the study vaccine with the adjuvants.

Detailed DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE HIV Infections
Intervention  ICMJE
  • Biological: HIV-1 gag DNA (formulated with bupivacaine)
  • Biological: IL-15 DNA (formulated with bupivacaine)
  • Biological: IL-12 DNA (formulated with bupivacaine)
  • Biological: Sodium chloride injection USP (0.9%)
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 Terminated
Estimated Enrollment  ICMJE
 (submitted: September 12, 2005)
91
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2007
Primary Completion DateNot Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Must be HIV positive.
  • Receiving stable HAART for a minimum of 6 consecutive months immediately before screening.
  • CD4 T-cell count greater than 350 mm cubed/mL at time of screening and no reported CD4 T-cell count less than 250 mm cubed/mL at any time before screening.

Other Inclusions Apply

Exclusion Criteria:

  • Any chronic symptomatic infection other than HIV.
  • History of diagnosed autoimmune disease (currently active or under control).
  • Use of any prior HIV vaccine (prophylactic and/or therapeutic) within one year before or during screening (documented, unblinded placebo recipients from previous clinical trials may participate without this time restriction).

Other Exclusions Apply

Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany,   Sweden,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00195312
Other Study ID Numbers  ICMJE 6120K1-100
Has Data Monitoring CommitteeNot Provided
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyNot Provided
Study Sponsor  ICMJE Wyeth is now a wholly owned subsidiary of Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Medical Monitor, MDWyeth is now a wholly owned subsidiary of Pfizer
Principal Investigator:Trial ManagerFor Germany, [email protected]
Principal Investigator:Trial ManagerFor Sweden, [email protected]
PRS AccountWyeth is now a wholly owned subsidiary of Pfizer
Verification DateDecember 2007

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

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

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