Study Evaluating Vaccine in Adults With HIV

This study has been terminated.
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00195312
First received: August 5, 2005
Last updated: December 3, 2007
Last verified: December 2007

August 5, 2005
December 3, 2007
August 2005
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  • To evaluate the safety and tolerability of intramuscular administration of HIV-1 gag DNA vaccine (total of three doses) in individuals on stable HAART
  • intramuscular administration of HIV-1 gag DNA vaccine when administered with increasing dosage levels of IL-12 DNA following each vaccine dose (total of three doses) in individuals on stable HAART
  • intramuscular administration of HIV-1 gag DNA vaccine when administered with increasing dosage levels of IL-15 DNA following each vaccine dose (total of three doses) in individuals on stable HAART
  • - intramuscular administration of HIV-1 gag DNA vaccine (total of three doses) in individuals on stable HAART.
  • - intramuscular administration of HIV-1 gag DNA vaccine when administered with increasing dosage levels of IL-12 DNA following each vaccine dose (total of three doses) in individuals on stable HAART.
  • - intramuscular administration of HIV-1 gag DNA vaccine when administered with increasing dosage levels of IL-15 DNA following each vaccine dose (total of three doses) in individuals on stable HAART.
  • To evaluate the safety and tolerability of:
Complete list of historical versions of study NCT00195312 on ClinicalTrials.gov Archive Site
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Study Evaluating Vaccine in Adults With HIV
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.

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.

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Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
HIV Infections
  • 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%)
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
91
August 2007
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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

Both
18 Years to 50 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Germany,   Sweden
 
NCT00195312
6120K1-100
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Wyeth is now a wholly owned subsidiary of Pfizer
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Study Director: Medical Monitor, MD Wyeth is now a wholly owned subsidiary of Pfizer
Principal Investigator: Trial Manager For Germany, MedinfoDEU@wyeth.com
Principal Investigator: Trial Manager For Sweden, MedInfoNord@wyeth.com
Wyeth is now a wholly owned subsidiary of Pfizer
December 2007

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