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Sponsors and Collaborators: |
National Institute of Allergy and Infectious Diseases (NIAID) Acute Infection and Early Disease Research Program Adult AIDS Clinical Trials Group |
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Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00183261 |
The purpose of this study is to determine whether the HIV vaccine MRKAd5 HIV-1 gag/pol/nef followed by treatment interruption can increase immune system function in adults with acute or recent HIV infection who have started taking anti-HIV drugs.
Condition | Intervention | Phase |
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HIV Infections |
Biological: MRKAd5 HIV-1 gag/pol/nef Biological: MRKAd5 HIV-1 gag/pol/nef placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized Phase II Study of Therapeutic Immunization and Treatment Interruption Among Subjects Who Began Potent Antiretroviral Therapy Within 30 Days of Diagnosis of Acute or Recent HIV Infection |
Enrollment: | 4 |
Study Start Date: | October 2005 |
Primary Completion Date: | December 2006 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Participants will receive the MRKAd5 HIV-1 gag/pol/nef vaccine at study entry and on Weeks 4 and 26
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Biological: MRKAd5 HIV-1 gag/pol/nef
1.5 x 1010 Ad vg/mL, 1.0 mL administered intramuscularly
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2: Placebo Comparator
Participants will receive the MRKAd5 HIV-1 gag/pol/nef vaccine placebo at study entry and on Weeks 4 and 26
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Biological: MRKAd5 HIV-1 gag/pol/nef placebo
1.0 mL administered intramuscularly
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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. Therapeutic vaccination within the earliest weeks following acute or recent HIV infection may increase the immune system's response to HIV. This study will determine whether MRKAd5 HIV-1 gag/pol/nef vaccine followed by treatment interruption can maintain viral suppression in patients with acute or recent HIV infection.
The interventional part of the study will last 102 weeks. Participants will be randomly assigned to receive either MRKAd5 HIV-1 gag/pol/nef or placebo vaccine at baseline and Weeks 4 and 26. Participants must remain on HAART from study entry until Week 38. Participants whose HIV viral load rebounds two times or more above 500 copies/ml by Weeks 39 to 41 will not enter Step 2 of the study. Participants whose viral load drops to 500 copies/ml or less by Weeks 39 to 41 will enter Step 2, where they will discontinue HAART for 24 weeks. Participants in Step 2 will have plasma HIV viral loads measured every 2 weeks for the first 4 weeks and weekly for the next 3 weeks. Study participants will continue in Step 2 until they experience virologic and immunologic failure or they need to restart HAART for another reason; they will then enter Step 3, where they will reinitiate HAART. Step 3 participants will continue on HAART until Week 102. A long-term safety follow-up period will occur from Weeks 103 to 240.
Timing of the study visits will be determined by which steps a participant enters. A physical exam and blood and urine collection will occur at most study visits throughout the study until Week 102. Follow-up phone calls to study participants will occur every 6 months from Week 102 until Week 240 to collect long-term safety data, including clinical status, CD4 count, and medication history. During the long-term safety follow-up, participants will also have study visits every 6 months. Visits will include medical and medication history.
Ages Eligible for Study: | 18 Years to 55 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, California | |
University of California-San Diego | |
San Diego, California, United States, 92103 | |
University of California-San Francisco | |
San Francisco, California, United States, 94114 | |
Harbor-UCLA | |
Culver City, California, United States, 90230 | |
United States, Colorado | |
University of Colorado Health Sciences Center | |
Denver, Colorado, United States, 80262-3706 | |
United States, Massachusetts | |
Fenway Community Health | |
Boston, Massachusetts, United States, 02115 | |
United States, Missouri | |
Washington University (St. Louis) | |
St. Louis, Missouri, United States, 63108-2138 | |
United States, New York | |
Aaron Diamond AIDS Research Center at Rockefeller | |
New York, New York, United States, 10021 | |
Beth Israel Medical Center | |
New York, New York, United States, 10003 | |
United States, North Carolina | |
University of North Carolina | |
Chapel Hill, North Carolina, United States, 27514 | |
Duke Univ. School of medicine | |
Durham, North Carolina, United States, 27710 | |
United States, Rhode Island | |
The Miriam Hospital | |
Providence, Rhode Island, United States, 02906 | |
American Samoa | |
St. Vincents Hospital | |
Darlinghurst, American Samoa, 2010 | |
Holdsworth House General | |
Darlinghurst, American Samoa, 2010 | |
407 Doctors | |
Surry Hills, American Samoa, 2010 | |
AIDS Research Initiative | |
Darlinghurst, American Samoa, 2010 | |
Taylor Square Private Clinic | |
Darlinghurst, American Samoa, 2010 |
Study Chair: | Susan Little, MD | University of California, San Diego AIDS Vaccine Research Center |
Study Chair: | Douglas D. Richman, MD | Departments of Pathology and Medicine, University of California, San Diego |
Responsible Party: | DAIDS ( Rona Siskind ) |
Study ID Numbers: | AIN504/ACTG A5218, AIN504-A5218 |
Study First Received: | September 13, 2005 |
Last Updated: | September 26, 2008 |
ClinicalTrials.gov Identifier: | NCT00183261 |
Health Authority: | United States: Food and Drug Administration |
Treatment Interruption HIV Therapeutic Vaccine Acute Infection Acute Retroviral Syndrome |
Virus Diseases Sexually Transmitted Diseases, Viral HIV Infections Sexually Transmitted Diseases |
Acquired Immunodeficiency Syndrome Retroviridae Infections Immunologic Deficiency Syndromes |
Communicable Diseases RNA Virus Infections Slow Virus Diseases |
Immune System Diseases Lentivirus Infections Infection |