skip navigation

Skip Nav

Ensayos clínicos

Ensayos clínicos

Safety of Recombinant HIV Vaccines in HIV Infected Young Adults on Stable Therapy

Patrocinador(es) del estudio: National Institute of Allergy and Infectious Diseases (NIAID)
Números de identificación: NCT00107549, PACTG P1059
  • Concluido

Propósito del estudio

The purpose of this study is to determine the safety of 4 recombinant HIV vaccines in HIV infected young adults on stable anti-HIV therapy. Study hypothesis: In HIV infected young adults who have well controlled HIV replication on highly active antiretroviral therapy (HAART), the two pairs of matching recombinant HIV-1 vaccines that utilize a modified vaccinia Ankara (MVA) vector and a fowlpox vector (FPV) will be safe and well tolerated.

Afección:Fase:
Infecciones por el VIH
Fase 1

Detalles del estudio

By helping to control viral replication, HAART has dramatically improved the prognosis for HIV infected individuals. However, because of extensive side effects, some of which may be acute and life-threatening, many patients find it difficult to tolerate a HAART regimen. HAART-associated long-term morbidity or mortality contribute to this difficulty. Administering an HIV therapeutic vaccine might allow HIV infected individuals to delay or interrupt treatment, avoiding the side effects associated with antiretroviral exposure. This study will evaluate the safety of 4 recombinant therapeutic vaccines in HIV infected young adults who are currently on stable HAART.



This study will last 72 weeks. All participants will receive 2 rMVA vaccines (env/gag and tat/rev/nef-RT) at study entry and at Week 4 and 2 rFPV vaccines (env/gag and tat/rev/nef-RT) at Weeks 8 and 24. Safety will be assessed immediately after each immunization and at 1 hour and 48 hours postimmunization. There will be 16 study visits over 72 weeks. A physical exam, blood collection, and administration of an adherence module will occur at most visits. An electrocardiogram (ECG) will occur at study entry and Weeks 2 and 10. Urine collection will occur at study entry and Weeks 4, 8, and 24.By helping to control viral replication, HAART has dramatically improved the prognosis for HIV infected individuals. However, because of extensive side effects, some of which may be acute and life-threatening, many patients find it difficult to tolerate a HAART regimen. HAART-associated long-term morbidity or mortality contribute to this difficulty. Administering an HIV therapeutic vaccine might allow HIV infected individuals to delay or interrupt treatment, avoiding the side effects associated with antiretroviral exposure. This study will evaluate the safety of 4 recombinant therapeutic vaccines in HIV infected young adults who are currently on stable HAART.



This study will last 72 weeks. All participants will receive 2 rMVA vaccines (env/gag and tat/rev/nef-RT) at study entry and at Week 4 and 2 rFPV vaccines (env/gag and tat/rev/nef-RT) at Weeks 8 and 24. Safety will be assessed immediately after each immunization and at 1 hour and 48 hours postimmunization. There will be 16 study visits over 72 weeks. A physical exam, blood collection, and administration of an adherence module will occur at most visits. An electrocardiogram (ECG) will occur at study entry and Weeks 2 and 10. Urine collection will occur at study entry and Weeks 4, 8, and 24.

Criterios de inclusión

    • HIV-1 infected
    • CD4 count of 350 cells/mm3 or greater
    • If hepatitis B or C infected, infection must be chronic and stable
    • Normal electrocardiogram (ECG)
    • On stable HAART consisting of at least 3 different antiretrovirals from 2 different classes AND with a viral load of less than 100 copies/ml for at least 6 months prior to study entry
    • Willing to use acceptable forms of contraception. Females enrolled in the study must use contraception for at least 21 days prior to first vaccination until the last study visit. Males enrolled in the study must use a condom from the first vaccination until one month after the last vaccination.
    • Willing to follow all study requirements
    • Available for follow-up for the duration of the study

Criterios de exclusión

    :
    • History of allergic reaction to eggs or egg products
    • Known hypersensitivity to vaccine components
    • Chemotherapy for active cancer in the 12 months prior to study entry
    • Prior vaccination with any HIV-1 vaccine
    • Prior vaccination against smallpox
    • Prior vaccinia immunization
    • Any immunization within 1 month of study screening
    • History of or known active heart disease including myocardial infarction, angina pectoris, congestive heart failure, cardiomyopathy, pericarditis, stroke or transient ischemic attack, chest pain or shortness of breath with activity such as walking upstairs, mitral valve prolapse, or other heart conditions under a doctor's care
    • Immunomodulatory agents, gamma globulin, or investigational agents within 6 months of study entry
    • Systemic steroids, including nonprescription street steroids, within 6 months of study entry
    • Documented or suspected serious bacterial infection, metabolic illness, cancer, or immediate life-threatening condition
    • Any clinically significant diseases other than HIV infection or clinically significant findings during study screening that, in the investigator's opinion, may interfere with the study
    • Current alcohol or drug abuse that, in the investigator's opinion, may interfere with the study
    • Pregnancy or breastfeeding

Centros de estudio/contactos

California

    Children's Hospital Los Angeles NICHD CRS, Los Angeles, California, 90027, United States

    Usc La Nichd Crs, Los Angeles, California, 90033, United States

Colorado

    Univ. of Colorado Denver NICHD CRS, Aurora, Colorado, 80218-1088, United States

Illinois

    Chicago Children's CRS, Chicago, Illinois, 60614, United States

Maryland

    Univ. of Maryland Baltimore NICHD CRS, Baltimore, Maryland, 60614, United States

New York

    Columbia IMPAACT CRS, New York, New York, 60614, United States

North Carolina

    DUMC Ped. CRS, Durham, North Carolina, 60614, United States

Tennessee

    St. Jude/UTHSC CRS, Memphis, Tennessee, 38105-2794, United States

    Univ. of Puerto Rico Ped. HIV/AIDS Research Program CRS, San Juan, Tennessee, 38105-2794, Puerto Rico

Actualizado: 16 de noviembre del 2005

Volver arriba