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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00107549
First received: April 5, 2005
Last updated: May 17, 2012
Last verified: May 2012

April 5, 2005
May 17, 2012
Not Provided
Not Provided
  • Development of any adverse events of Grade 3 or higher [ Time Frame: Throughout study ] [ Designated as safety issue: Yes ]
  • Development of adverse events of Grade 3 or higher attributed to the study vaccines [ Time Frame: Throughout study ] [ Designated as safety issue: Yes ]
  • Viral breakthrough to greater than 1,000 copies/ml [ Time Frame: During the first 24 weeks of study ] [ Designated as safety issue: No ]
  • Development of any adverse events of Grade 3 or higher
  • development of adverse events of Grade 3 or higher attributed to the study vaccines
  • viral breakthrough to greater than 1,000 copies/ml within the first 26 weeks on study
Complete list of historical versions of study NCT00107549 on ClinicalTrials.gov Archive Site
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Safety of Recombinant HIV Vaccines in HIV Infected Young Adults on Stable Therapy
A Phase I, Open-Label Study to Evaluate the Safety and Tolerability of Recombinant HIV-1 Vaccines in HIV-1 Infected Young Adults With Control of HIV-1 Replication and on Stable Highly Active Antiretroviral Therapy (HAART)

The purpose of this study is to determine the safety of two recombinant HIV vaccines in HIV infected young adults on stable anti-HIV therapy.

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 two injections of two recombinant therapeutic vaccines in HIV infected young adults who are currently on stable HAART.

This study will last 72 weeks. All participants will receive two rMVA vaccines (env/gag and tat/rev/nef-RT) at study entry and at Week 4 and two 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.

Interventional
Phase 1
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
HIV Infections
  • Biological: rMVA-HIV (env/gag [TBC-M358] + tat/rev/nef-RT [TBC-M335)])
    Recombinant experimental therapeutic vaccine using the modified vaccinia Ankara vector given at study entry and Week 4
  • Biological: rFPV-HIV (env/gag [TBC-F357] + tat/rev/nef-RT [TBC-F349])
    Recombinant experimental therapeutic vaccine using fowlpox vector given at Weeks 8 and 24
Experimental: 1
All participants in this study will receive two injections of the rMVA-HIV vaccine and the rFPV-HIV vaccine
Interventions:
  • Biological: rMVA-HIV (env/gag [TBC-M358] + tat/rev/nef-RT [TBC-M335)])
  • Biological: rFPV-HIV (env/gag [TBC-F357] + tat/rev/nef-RT [TBC-F349])

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
February 2009
Not Provided

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Both
18 Years to 24 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Puerto Rico
 
NCT00107549
P1059, 10051, PACTG P1059
Not Provided
National Institute of Allergy and Infectious Diseases (NIAID)
National Institute of Allergy and Infectious Diseases (NIAID)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Study Chair: Coleen K. Cunningham, MD Pediatric Infectious Diseases, Duke University
National Institute of Allergy and Infectious Diseases (NIAID)
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP