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.

Wyeth is now a wholly owned subsidiary of Pfizer0 sites60 target enrollmentDecember 2004

ConditionsHIV Infections

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: HIV Infections
Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Enrollment: 60
Primary Endpoint: 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.
Status: Completed
Last Updated: 18 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

December 2004

End Date

February 2007

Last Updated

18 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Eligibility Criteria

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

Outcomes

Primary Outcomes

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.

Secondary Outcomes

To evaluate the subject immune system responds to the vaccinations. To evaluate RNA and protein patterns in the collected blood samples after vaccination.