NCT00056797

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

Completed Phase 2 Last updated 13 December 2016

What this trial tests

Phase 2 trial testing ALVAC HIV vaccine (vCP1452) in HIV Infections in 92 participants. Completed in 1 March 2006.

Timeline

1 March 2002

Primary endpoint
1 March 2006

1 March 2006

Quick facts

Lead sponsor	National Institute of Allergy and Infectious Diseases (NIAID)
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	factorial
Masking	single
Primary purpose	treatment
Enrollment	92
Start date	1 March 2002
Primary completion	1 March 2006
Estimated completion	1 March 2006
Sites	1 location across United States

Drugs / interventions tested

• ALVAC HIV vaccine (vCP1452) — full drug profile →
• Interleukin-2

Conditions studied

• HIV Infections — all drugs for HIV Infections →

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Who can join

Adults 18 to 65, any sex, with HIV Infections. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• 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

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Perspectives for immunotherapy: which applications might achieve an HIV functional cure?
   Vieillard V, Gharakhanian S, Lucar O, Katlama C, et al · · 2016 · cited 10× · PMID 26950274 · DOI 10.18632/oncotarget.7793
2. Immunotherapy with canarypox vaccine and interleukin-2 for HIV-1 infection: termination of a randomized trial.
   Smith KA, Andjelic S, Popmihajlov Z, Kelly-Rossini L, et al · · 2007 · cited 9× · PMID 17260026 · DOI 10.1371/journal.pctr.0020005
3. Advances in host-directed therapy for tuberculosis and HIV coinfection: enhancing immune responses.
   Prasanna P, Herrera B, Schlesinger LS, Paiardini M, et al · · 2025 · cited 3× · PMID 40345900 · DOI 10.1016/j.tim.2025.04.006