Therapeutic HIV Vaccine and Interleukin-2 to Increase the Immune System's Response to HIV
NCT ID: NCT00056797
Last Updated: 2016-12-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
92 participants
INTERVENTIONAL
2002-03-31
2006-03-31
Brief Summary
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Detailed Description
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This trial will evaluate the use of the ALVAC vCP1452 vaccine in combination with IL-2 to increase HIV-specific immune responses in HIV infected patients. ALVAC vCP1452 vaccine is a recombinant canarypox HIV vaccine that is administered as a monthly intramuscular injection. The IL-2 is self administered as a daily subcutaneous injection at a low, non-toxic dose (2 million units).
Participants in this study are randomized to receive either ALVAC and IL-2 or placebo for the first 3 months of the study. During this time, participants will continue on their current antiretroviral medications and have monthly study visits. Study visits will include a brief medical interview and physical exam, administration of the vaccine, and blood tests. At the end of 3 months, participants will discontinue both their study medications (IL-2 and ALVAC or placebo) and their antiretroviral medications. This Diagnostic Treatment Interruption (DTI) will continue for a minimum of 3 months. During the DTI, participants will have weekly study visits in which viral and lymphocyte dynamics are monitored.
Conditions
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Keywords
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
SINGLE
Interventions
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ALVAC HIV vaccine (vCP1452)
Interleukin-2
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
18 Years
65 Years
ALL
No
Sponsors
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National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Principal Investigators
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Kendall A. Smith, MD
Role: PRINCIPAL_INVESTIGATOR
Weill Medical College of Cornell University
Locations
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NY Presbyterian Weill Cornell Medical Center
New York, New York, United States
Countries
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Other Identifiers
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