Study Evaluating Vaccine in Adults With HIV

Wyeth

Status and phase

Completed

Phase 1

Conditions

HIV Infections

Treatments

Biological: HIV CTL MEP 1000 micrograms, 19 months per subject

Study type

Interventional

Funder types

Industry

Identifiers

NCT00195234

6112K2-100

Details and patient eligibility

About

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.

Sex

All

Ages

18+ years old

Volunteers

No 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