HIV Infections Clinical Trial
Official title:
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vaccine and/or interleukin-2 (IL-2) will control viral load (amount of HIV in the blood) after HIV treatment is withdrawn for a certain time period.
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.
;
Masking: Double-Blind, Primary Purpose: Treatment
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