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Therapeutic HIV Vaccine and Interleukin-2 to Increase the Immune System's Response to HIV
This study has been completed.
Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by:
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00056797
First received: March 24, 2003
Last updated: December 13, 2016
Last verified: July 2007
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
| HIV Infections | Biological: ALVAC HIV vaccine (vCP1452) Drug: Interleukin-2 | Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Factorial Assignment Masking: Single Blind Primary Purpose: Treatment |
| Official Title: | A Randomized Controlled Study Testing the Efficacy of Immunotherapies to Control Plasma HIV RNA Concentrations Upon Interruption of Highly Active Antiretroviral Therapy (HAART). |
Resource links provided by NLM:
Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):
Primary Outcome Measures:
- Mean log10 viral load for each experimental group from the average of 5 values obtained during Weeks 21 to 25, corresponding to 8 to 12 weeks following the interruption of HAART
Secondary Outcome Measures:
- Proportion of subjects who relapse during the first 12 weeks following cessation of HAART
- length of time to the termination of Step II
- changes in frequency, activation state, and HIV-specific functional capacity of T cells and NK cells in blood, as monitored by the expression of intracellular cytokines during the first 12 weeks after cessation of HAART
| Estimated Enrollment: | 92 |
| Study Start Date: | March 2002 |
| Study Completion Date: | March 2006 |
| Primary Completion Date: | March 2006 (Final data collection date for primary outcome measure) |
While the advent of highly active antiretroviral therapy (HAART) has contributed to the increasing control of HIV infection and viral replication, ultimate control of HIV infection will require the development of effective HIV-specific immunity in HIV infected individuals.
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.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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)
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00056797
Please refer to this study by its ClinicalTrials.gov identifier: NCT00056797
Locations
| United States, New York | |
| NY Presbyterian Weill Cornell Medical Center | |
| New York, New York, United States, 10021 | |
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
| Principal Investigator: | Kendall A. Smith, MD | Weill Medical College of Cornell University |
More Information
Additional Information:
| ClinicalTrials.gov Identifier: | NCT00056797 History of Changes |
| Other Study ID Numbers: |
1R01AI051181-01A1 ( U.S. NIH Grant/Contract ) 0900-397 |
| Study First Received: | March 24, 2003 |
| Last Updated: | December 13, 2016 |
Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
|
HIV Therapeutic vaccine IL-2 Structured Treatment Interruption Treatment Experienced |
Additional relevant MeSH terms:
|
HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases |
Vaccines Interleukin-2 Immunologic Factors Physiological Effects of Drugs Antineoplastic Agents Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents |
ClinicalTrials.gov processed this record on July 17, 2017