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Immune Therapies and Anti-HIV Therapy Withdrawal in Controlling Viral Load

Primary Purpose

HIV Infections

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
ALVAC(2)120(B,MN)GNP (vCP1452)
Aldesleukin
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 Virus Replication, HIV-1, AIDS Vaccines, RNA, Viral, Avipoxvirus, Genetic Vectors, Viral Load, aldesleukin, Antiretroviral Therapy, Highly Active, HIV Therapeutic Vaccine, Treatment Interruption

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria Patients may be eligible for this study if they: Are HIV-positive. Are more than 18 years old. Have been receiving their current HAART (2 or more anti-HIV drugs in combination) for more than 6 consecutive months. Have a CD4 count of 200 cells/microL or more within the 12 months prior to entering the study and 400 cells/microL or more on 2 occasions at least 2 weeks apart within 30 days of entry. Have never had a viral load higher than 2 million molecules/ml and have had the viral load controlled with HAART to less than 50 molecules/ml on 2 occasions at least 2 weeks apart within 30 days of entry. Have not had virologic failure on the current HAART regimen. Have a negative urine pregnancy test within 14 days of entering the study. Exclusion Criteria Patients will not be eligible for this study if they: Have a current AIDS-defining illness. Have had failure of the current HAART regimen (viral load higher than 10,000 molecules/ml). Have a history of using agents affecting the immune system. Have active uncontrolled heart disease. Have had IL-2 therapy within 4 weeks of entering the study. Have received other treatment that affects the immune system within 4 weeks of entry. Have a history of a cancer requiring chemotherapy. Have untreated thyroid disease, within 4 weeks of entering the study. Have uncontrolled allergic disorders or autoimmune diseases, including asthma, inflammatory bowel disease, and psoriasis. Abuse substances that may interfere with the ability to follow study requirements. Are allergic to eggs. Have hepatitis B or hepatitis C. Are pregnant or breast-feeding. Work in close contact with canaries, such as a job at breeding farms or bird shops.

Sites / Locations

  • New York Hosp - Cornell Med Ctr

Outcomes

Primary Outcome Measures

Mean log10 viral load for each experimental group from the average of 5 values obtained during Weeks 21 to 25 (8 to 12 weeks following HAART interruption

Secondary Outcome Measures

Proportion of participants who relapse during the first 12 weeks following stopping of HAART
length of time to the termination of Step II among participants
changes in frequency, activation state, and HIV-specific functional capacity of T and NK cells in blood, as monitored by expression of intracellular cytokines during the first 12 weeks after stopping HAART, with respect to termination of Step II

Full Information

First Posted
March 27, 2001
Last Updated
November 1, 2012
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators
New York Presbyterian Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00013663
Brief Title
Immune Therapies and Anti-HIV Therapy Withdrawal in Controlling Viral Load
Official Title
A Randomized Controlled Study Testing the Efficacy of Immunotherapies to Control Plasma HIV RNA Concentrations Upon Interruption of Highly Active Antiretroviral Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
June 2006
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators
New York Presbyterian Hospital

4. Oversight

5. Study Description

Brief Summary
The purpose of this study is to determine if HIV-specific canarypox vaccine and/or interleukin-2 (IL-2) will control viral load (amount of HIV in the blood) after HIV treatment is withdrawn for a certain time period.
Detailed Description
Step I: In addition to continuing HAART, patients are randomized into 1 of the following 4 arms: A: Immunization placebo; B: Immunization with the canarypox HIV-vaccine (vCP1452); C: Daily low-dose IL-2 + immunization placebo; or D: Daily low-dose IL-2 + canarypox HIV-vaccine (vCP1452). Patients on Arms A, B, C, and D receive vaccine (or vaccine placebo) injections at Weeks 0, 4, 8, and 12. Patients on Arms C and D receive IL-2 by self-injection. HAART is not provided as part of this study. Step II: Patients on all arms (A, B, C, and D) who meet inclusion criteria advance to Step II and interrupt HAART for a minimum of 12 weeks. The efficacy of these immunological therapies will be determined by monitoring the dynamics of viral rebound upon cessation of antiviral therapy. After 12 weeks of Step II, patients whose viral load remains below 30,000 copies/ml remain on Step II, off HAART, and continue weekly viral load monitoring. Patients will not terminate Step II or resume HAART unless and until their viral load increases to more than 30,000 copies/ml on 3 successive determinations, or their CD4 count decreases to less than 200 cells/mm3 or less than 50 percent of the baseline CD4+ T cell concentration on 2 successive occasions.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Virus Replication, HIV-1, AIDS Vaccines, RNA, Viral, Avipoxvirus, Genetic Vectors, Viral Load, aldesleukin, Antiretroviral Therapy, Highly Active, HIV Therapeutic Vaccine, Treatment Interruption

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Masking
Double
Enrollment
92 (false)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
ALVAC(2)120(B,MN)GNP (vCP1452)
Intervention Type
Drug
Intervention Name(s)
Aldesleukin
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 (8 to 12 weeks following HAART interruption
Secondary Outcome Measure Information:
Title
Proportion of participants who relapse during the first 12 weeks following stopping of HAART
Title
length of time to the termination of Step II among participants
Title
changes in frequency, activation state, and HIV-specific functional capacity of T and NK cells in blood, as monitored by expression of intracellular cytokines during the first 12 weeks after stopping HAART, with respect to termination of Step II

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria Patients may be eligible for this study if they: Are HIV-positive. Are more than 18 years old. Have been receiving their current HAART (2 or more anti-HIV drugs in combination) for more than 6 consecutive months. Have a CD4 count of 200 cells/microL or more within the 12 months prior to entering the study and 400 cells/microL or more on 2 occasions at least 2 weeks apart within 30 days of entry. Have never had a viral load higher than 2 million molecules/ml and have had the viral load controlled with HAART to less than 50 molecules/ml on 2 occasions at least 2 weeks apart within 30 days of entry. Have not had virologic failure on the current HAART regimen. Have a negative urine pregnancy test within 14 days of entering the study. Exclusion Criteria Patients will not be eligible for this study if they: Have a current AIDS-defining illness. Have had failure of the current HAART regimen (viral load higher than 10,000 molecules/ml). Have a history of using agents affecting the immune system. Have active uncontrolled heart disease. Have had IL-2 therapy within 4 weeks of entering the study. Have received other treatment that affects the immune system within 4 weeks of entry. Have a history of a cancer requiring chemotherapy. Have untreated thyroid disease, within 4 weeks of entering the study. Have uncontrolled allergic disorders or autoimmune diseases, including asthma, inflammatory bowel disease, and psoriasis. Abuse substances that may interfere with the ability to follow study requirements. Are allergic to eggs. Have hepatitis B or hepatitis C. Are pregnant or breast-feeding. Work in close contact with canaries, such as a job at breeding farms or bird shops.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kendall A. Smith, MD
Organizational Affiliation
Division of Immunology, Department of Medicine, Weill Medical College, Cornell University
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York Hosp - Cornell Med Ctr
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States

12. IPD Sharing Statement

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Immune Therapies and Anti-HIV Therapy Withdrawal in Controlling Viral Load

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