Therapeutic HIV Vaccine and Interleukin-2 to Increase the Immune System's Response to HIV

• Status: Completed
• Trial end date: 2006-03-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will evaluate whether the HIV vaccine ALVAC vCP1452 given in combination with interleukin-2 (IL-2), also known as aldesleukin, can increase immune system function in people with HIV infection.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Treatments: Interleukin-2; Vaccines

Criteria

Inclusion Criteria

• HIV infected

• Stable HAART, defined as two or more antiretroviral drugs in combination. Changes in drugs are allowed if for any reason other than virologic failure.

• CD4 cell count > 200 cells/ml for the 12 months prior to enrollment

• CD4 cell count >= 400 cells/ml on two successive occasions at least 14 days apart within 30 days of study entry

• HIV RNA < 2 million copies/ml, with suppression on HAART to < 50 copies/ml on two successive occasions at least 14 days apart within 30 days of entry

• Acceptable methods of contraception

Exclusion Criteria

• Current AIDS-defining illness

• Virologic failure (HIV RNA > 10,000 copies/ml) while receiving current HAART regimen

• Immunomodulating agents, including interleukins; antibodies reactive with lymphocytes, monocytes, or antigen presenting cells; and polyribonucleotides

• IL-2 therapy within 4 weeks of study entry

• Uncontrolled active cardiac, renal, pulmonary, hepatic, or CNS disease

• History of active malignancy requiring chemotherapy

• History of thyroid disease or autoimmune disorders, including asthma, inflammatory bowel disease, rheumatoid arthritis, and psoriasis

• Active infection with hepatitis B virus or hepatitis C virus

• Severe retinopathy due to diabetes, hypertension, CMV, or macular degeneration

• Serious infection or other serious medical illness that is potentially life threatening and requires systemic therapy and/or hospitalization within 14 days of study entry

• Substance abuse that will compromise the participant's ability to adhere to the study requirements

• Current alcohol use of more than 1 drink/day any time during 6 months prior to study entry. One drink is defined as 12 ounces of beer, 5 ounces of wine, or 1.25 ounces of hard liquor.

• History of allergy to eggs, IL-2, or other components of the vaccine or IL-2 formulation

• Pregnant or breast-feeding

• Professionals working in close contact with canaries (e.g., breeding farms, bird shops)