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

This study has been suspended.

Sponsors and Collaborators: National Institute of Allergy and Infectious Diseases (NIAID)
National Institute of Child Health and Human Development (NICHD)
Information provided by: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00107549
  Purpose

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.


Condition Intervention Phase
HIV Infections
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])
Phase I

MedlinePlus related topics:   AIDS   

ChemIDplus related topics:   PANVAC-V   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Official Title:   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)

Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment:   16
Study Start Date:   July 2006
Estimated Study Completion Date:   July 2008

Arms Assigned Interventions
1: Experimental
All participants in this study will receive two injections of the rMVA-HIV vaccine and the rFPV-HIV vaccine
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

Detailed Description:

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.

  Eligibility
Ages Eligible for Study:   18 Years to 24 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00107549

Show 26 study locations  Show 26 Study Locations

Sponsors and Collaborators

Investigators
Study Chair:     Coleen K. Cunningham, MD     Pediatric Infectious Diseases, Duke University    
  More Information


Haga clic aquí para ver información sobre este ensayo clínico en español.  This link exits the ClinicalTrials.gov site
 

Publications:

Study ID Numbers:   PACTG P1059
First Received:   April 5, 2005
Last Updated:   July 29, 2008
ClinicalTrials.gov Identifier:   NCT00107549
Health Authority:   United States: Food and Drug Administration

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Treatment Experienced  
HIV Therapeutic Vaccine  

Study placed in the following topic categories:
Virus Diseases
Sexually Transmitted Diseases, Viral
HIV Infections
Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:
RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
Lentivirus Infections
Infection

ClinicalTrials.gov processed this record on September 23, 2008




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