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

Primary Purpose

HIV Infections

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
ALVAC HIV vaccine (vCP1452)
Interleukin-2
Sponsored by
National Institute of Allergy and Infectious Diseases (NIAID)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring HIV Therapeutic vaccine, IL-2, Structured Treatment Interruption, Treatment Experienced

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • NY Presbyterian Weill Cornell Medical Center

Outcomes

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

Full Information

First Posted
March 24, 2003
Last Updated
December 13, 2016
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
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1. Study Identification

Unique Protocol Identification Number
NCT00056797
Brief Title
Therapeutic HIV Vaccine and Interleukin-2 to Increase the Immune System's Response to HIV
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).
Study Type
Interventional

2. Study Status

Record Verification Date
July 2007
Overall Recruitment Status
Completed
Study Start Date
March 2002 (undefined)
Primary Completion Date
March 2006 (Actual)
Study Completion Date
March 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)

4. Oversight

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
HIV Therapeutic vaccine, IL-2, Structured Treatment Interruption, Treatment Experienced

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Factorial Assignment
Masking
Single
Allocation
Randomized
Enrollment
92 (false)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
ALVAC HIV vaccine (vCP1452)
Intervention Type
Drug
Intervention Name(s)
Interleukin-2
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Proportion of subjects who relapse during the first 12 weeks following cessation of HAART
Title
length of time to the termination of Step II
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kendall A. Smith, MD
Organizational Affiliation
Weill Medical College of Cornell University
Official's Role
Principal Investigator
Facility Information:
Facility Name
NY Presbyterian Weill Cornell Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States

12. IPD Sharing Statement

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

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