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

Sponsor:	National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by:	National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:	NCT00056797

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 II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study 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:

Genetics Home Reference related topics: complement factor I deficiency

MedlinePlus related topics: HIV/AIDS

Drug Information available for: Interleukin-2

U.S. FDA Resources

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

Detailed Description:

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
Genders Eligible for Study:	Both
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

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:

Click here for more information on aldesleukin This link exits the ClinicalTrials.gov site

Click here for more information on therapeutic HIV vaccines This link exits the ClinicalTrials.gov site

Click here for more information about Dr. Kendall Smith's HIV and HCV Interleukin 2 Resource Site This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier:	NCT00056797 History of Changes
Other Study ID Numbers:	1R01AI51181-01A1, 0900-397, 1 R01AI51181-01A1
Study First Received:	March 24, 2003
Last Updated:	June 18, 2010
Health Authority:	United States: Food and Drug Administration

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
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

Interleukin-2
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 09, 2012