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

Phase 2

Completed

• Conditions: HIV Infections

• Registration Number: NCT00013663
• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

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vaccine and/or interleukin-2 (IL-2) will control viral load (amount of HIV in the blood) after HIV treatment is withdrawn for a certain time period.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

Study Timeline

• Study First Submitted: 2001-03-27
• Study First Submitted QC: 2001-08-30
• Study First Posted: 2001-08-31
• Status Verified: 2006-06
• Study Completion: 2006-06
• Last Update Submitted: 2012-11-01
• Last Update Posted: 2012-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 92

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
length of time to the termination of Step II among participants
Proportion of participants who relapse during the first 12 weeks following stopping of HAART
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

Trial Locations

Locations (1)

New York Hosp - Cornell Med Ctr; 🇺🇸 New York, New York, United States