HIV Vaccine Designed for HIV Infected Adults Taking Anti-HIV Drugs

National Institute of Allergy and Infectious Diseases (NIAID)

Status and phase

Completed

Phase 1

Conditions

HIV Infections

Treatments

Biological: Autologous Dendritic Cell HIV Vaccination

Study type

Interventional

Funder types

NIH

Identifiers

NCT00056758

P01AI043664-04 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

This study will evaluate the safety of and immune responses to a dendritic cell vaccination for HIV-1 infection. The vaccine will be made from a patient's own cells combined with small fragments of HIV-1 (made synthetically in a laboratory). These cells will be administered back to the patient either into a vein (intravenously) or the skin (subcutaneously).

Full description

Untreated HIV-1 infection is characterized by progressive immune dysfunction and the development of opportunistic infections and AIDS-associated malignancies. Highly active antiretroviral therapy (HAART) has been successful in suppressing HIV replication and restoring partial immune function. However, HIV-specific immunity remains poor, as evidenced by rapid rebound of HIV-1 RNA following HAART withdrawal. Studies of individuals with acute HIV-1 infection, as well as those who are long-term nonprogressors, have suggested that robust HIV-specific immune responses are associated with control of HIV-1 viremia. Dendritic cells (DCs) are potent antigen presenting cells that may increase HIV-specific immune responses. This protocol will evaluate the use of DCs to help control HIV infection.

Patients will be randomized to receive either intravenous or subcutaneous administration of HIV antigen expressing DCs. Each subject will receive two administrations of mature DCs given 3 weeks apart. Subjects will be followed weekly for 8 weeks, then at Weeks 12, 16, 24, 36, and 48. Two doses of DCs will be evaluated (low dose: 1-3 million cells; high dose: 5-10 million cells) for safety and immune system response.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

HIV-1 infection
Current CD4 count more than 400/mm3
HIV RNA less than 400 copies/ml
Stable combination antiretroviral therapy for at least 4 weeks prior to study entry
HLA A2.1 (to be tested at screening)

Exclusion criteria