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

Completed · Phase 2

Conditions studied: HIV Infections

In brief

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.

Key facts

Study ID

NCT00056797

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

92

Starts

2002-03-01

Expected to finish

2006-03-01

Last updated by the study team

2016-12-14

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• NY Presbyterian Weill Cornell Medical Center — New York, New York, United States

Full record on ClinicalTrials.gov

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