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.

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00195234

Enrollment

Registered

2005-09-19

Start date

2004-12-31

Completion date

2007-02-28

Last updated

2007-12-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infections

Keywords

HIV, Treatment Experienced

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.

Interventions

BIOLOGICALHIV CTL MEP 1000 micrograms, 19 months per subject

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026