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Therapeutic HIV Vaccine and Interleukin-2 to Increase the Immune System's Response to HIV

13 décembre 2016 mis à jour par: 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 (HAART).

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.

Aperçu de l'étude

Statut

Complété

Les conditions

Infections à VIH

Intervention / Traitement

Description détaillée

While the advent of highly active antiretroviral therapy (HAART) has contributed to the increasing control of HIV infection and viral replication, ultimate control of HIV infection will require the development of effective HIV-specific immunity in HIV infected individuals.

This trial will evaluate the use of the ALVAC vCP1452 vaccine in combination with IL-2 to increase HIV-specific immune responses in HIV infected patients. ALVAC vCP1452 vaccine is a recombinant canarypox HIV vaccine that is administered as a monthly intramuscular injection. The IL-2 is self administered as a daily subcutaneous injection at a low, non-toxic dose (2 million units).

Participants in this study are randomized to receive either ALVAC and IL-2 or placebo for the first 3 months of the study. During this time, participants will continue on their current antiretroviral medications and have monthly study visits. Study visits will include a brief medical interview and physical exam, administration of the vaccine, and blood tests. At the end of 3 months, participants will discontinue both their study medications (IL-2 and ALVAC or placebo) and their antiretroviral medications. This Diagnostic Treatment Interruption (DTI) will continue for a minimum of 3 months. During the DTI, participants will have weekly study visits in which viral and lymphocyte dynamics are monitored.

Type d'étude

Interventionnel

Inscription

Phase

Phase 2

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

États-Unis
- New York
  - New York, New York, États-Unis, 10021
    - NY Presbyterian Weill Cornell Medical Center

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans à 65 ans (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

Inclusion Criteria

HIV infected
Stable HAART, defined as two or more antiretroviral drugs in combination. Changes in drugs are allowed if for any reason other than virologic failure.
CD4 cell count > 200 cells/ml for the 12 months prior to enrollment
CD4 cell count >= 400 cells/ml on two successive occasions at least 14 days apart within 30 days of study entry
HIV RNA < 2 million copies/ml, with suppression on HAART to < 50 copies/ml on two successive occasions at least 14 days apart within 30 days of entry
Acceptable methods of contraception

Exclusion Criteria

Current AIDS-defining illness
Virologic failure (HIV RNA > 10,000 copies/ml) while receiving current HAART regimen
Immunomodulating agents, including interleukins; antibodies reactive with lymphocytes, monocytes, or antigen presenting cells; and polyribonucleotides
IL-2 therapy within 4 weeks of study entry
Uncontrolled active cardiac, renal, pulmonary, hepatic, or CNS disease
History of active malignancy requiring chemotherapy
History of thyroid disease or autoimmune disorders, including asthma, inflammatory bowel disease, rheumatoid arthritis, and psoriasis
Active infection with hepatitis B virus or hepatitis C virus
Severe retinopathy due to diabetes, hypertension, CMV, or macular degeneration
Serious infection or other serious medical illness that is potentially life threatening and requires systemic therapy and/or hospitalization within 14 days of study entry
Substance abuse that will compromise the participant's ability to adhere to the study requirements
Current alcohol use of more than 1 drink/day any time during 6 months prior to study entry. One drink is defined as 12 ounces of beer, 5 ounces of wine, or 1.25 ounces of hard liquor.
History of allergy to eggs, IL-2, or other components of the vaccine or IL-2 formulation
Pregnant or breast-feeding
Professionals working in close contact with canaries (e.g., breeding farms, bird shops)

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Objectif principal: Traitement
Répartition: Randomisé
Modèle interventionnel: Affectation factorielle
Masquage: Seul

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
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

Mesures de résultats secondaires

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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

National Institute of Allergy and Infectious Diseases (NIAID)

Les enquêteurs

Chercheur principal: Kendall A. Smith, MD, Weill Medical College of Cornell University

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 mars 2002

Achèvement primaire (Réel)

1 mars 2006

Achèvement de l'étude (Réel)