Study Evaluating Vaccine in Adults With HIV

This study has been completed.
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00195234
First received: September 12, 2005
Last updated: December 3, 2007
Last verified: December 2007

September 12, 2005
December 3, 2007
December 2004
Not Provided
To evaluate the safety and tolerability of the HIV CTL MEP vaccine formulated with adjuvants, administered by intramuscular (IM) injection to HIV Pos adults receiving stable HAART. Subjects will receive vaccinations at months 0, 1, 3, and 6.
Same as current
Complete list of historical versions of study NCT00195234 on ClinicalTrials.gov Archive Site
To evaluate the subject immune system responds to the vaccinations. To evaluate RNA and protein patterns in the collected blood samples after vaccination.
Same as current
Not Provided
Not Provided
 
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 CTL Multi-Epitope Peptide Vaccine Formulated With RC529-SE and GM-CSF Given to HIV-1 Positive Adults on Stable HAART.

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

A second purpose of this study is to understand how the immune system responds to the study vaccine and adjuvants.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
HIV Infections
Biological: HIV CTL MEP 1000 micrograms, 19 months per subject
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
February 2007
Not Provided

Inclusion Criteria:

  • 18 years of age diagnosed with HIV and on stable HAART for a minimum of six months
  • CD4 T-cell count greater than and equal to 350/mm3 at screening
  • No reported CD4 T-cell count less than 350/mm3 at any time before screening
  • Viral load less than 50 copies/mL at screening and no viral load greater than 400 copies/mL for a minimum of six months prior to screening

Exclusion Criteria:

  • Any chronic symptomatic infection other than HIV
  • Use of any prior HIV vaccine (prophylactic and/or therapeutic) within one year before or during screening
  • Any malignancy that may require systemic therapy
  • Use of any investigational treatment within six months before screening or planned during study enrollment, except for investigational retrovirals obtained through ACTG
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00195234
6112K2-100
Not Provided
Not Provided
Wyeth is now a wholly owned subsidiary of Pfizer
Not Provided
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
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