Study Evaluating Vaccine in Adults With HIV

Wyeth

Status and phase

Terminated

Phase 1

Conditions

HIV Infections

Treatments

Biological: IL-12 DNA (formulated with bupivacaine)

Biological: Sodium chloride injection USP (0.9%)

Biological: IL-15 DNA (formulated with bupivacaine)

Biological: HIV-1 gag DNA (formulated with bupivacaine)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00195312

6120K1-100

Details and patient eligibility

About

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.

Enrollment

91 estimated patients

Sex

All

Ages

18 to 50 years old

Volunteers

No Healthy Volunteers

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