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

November 1, 2012 updated by: National Institute of Allergy and Infectious Diseases (NIAID)

A Randomized Controlled Study Testing the Efficacy of Immunotherapies to Control Plasma HIV RNA Concentrations Upon Interruption of Highly Active Antiretroviral Therapy

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vaccine and/or interleukin-2 (IL-2) will control viral load (amount of HIV in the blood) after HIV treatment is withdrawn for a certain time period.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment

92

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10021
        • New York Hosp - Cornell Med Ctr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborators

New York Presbyterian Hospital

Investigators

  • Principal Investigator: Kendall A. Smith, MD, Division of Immunology, Department of Medicine, Weill Medical College, Cornell University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Completion (Actual)

June 1, 2006

Study Registration Dates

First Submitted

March 27, 2001

First Submitted That Met QC Criteria

August 30, 2001

First Posted (Estimate)

August 31, 2001

Study Record Updates

Last Update Posted (Estimate)

November 2, 2012

Last Update Submitted That Met QC Criteria

November 1, 2012

Last Verified

June 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B012
  • 0900-397

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on HIV Infections

Clinical Trials on Aldesleukin

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Peru

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe