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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 |
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 |
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) |
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
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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
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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.
Ages Eligible for Study: | 18 Years to 24 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Show 26 Study Locations |
National Institute of Allergy and Infectious Diseases (NIAID) |
National Institute of Child Health and Human Development (NICHD) |
Study Chair: | Coleen K. Cunningham, MD | Pediatric Infectious Diseases, Duke University |
Haga clic aquí para ver información sobre este ensayo clínico en español. 
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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 |
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