Safety of and Immune Response to a DNA HIV Vaccine (VRC-HIVDNA009-00-VP) in HIV Infected Individuals With Acute HIV Infection
NCT ID: NCT00125099
Last Updated: 2021-11-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
21 participants
INTERVENTIONAL
2007-09-30
Brief Summary
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Detailed Description
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Participants in this study will be randomly assigned to receive either the therapeutic vaccine or placebo in addition to their regular HAART regimens. During the first part of the study, participants will receive 4 vaccinations at Weeks 0, 4, 8 and 24. All individuals completing the therapeutic vaccination phase (defined as completing at least 3 immunizations, including the Week 24 immunization) will be given the opportunity to participate in the second part of the study and undergo a supervised discontinuation of HAART. At Week 30, these participants will discontinue all antiretroviral treatment and will be closely monitored. Participants will restart HAART if they experience a significant decline in their CD4 count, an increase in their viral loads, or if their physicians recommend they resume HAART. At Week 52, all other participants can restart HAART at the discretion of their primary physician.
21 study visits will occur over a period of 52 weeks. After Week 52, monthly study visits will occur through Week 72. Study visits will last approximately two hours and will include physical exams and blood and urine collection.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
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VRC-HIVDNA009-00-VP
Eligibility Criteria
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Inclusion Criteria
* Minimum of 6 months of HAART, defined as 2 or more antiretroviral drugs in combination
* At least three CD4 cell counts over 350 cells/mm3 for a period of 6 months prior to study entry
* Screening CD4 cell count over 350 cells/mm3 within 30 days prior to study entry
* HIV-1 RNA levels over 50 copies/ml for a period of 6 months prior to study entry
* Screening HIV-1 RNA level less than 50 copies/ml within 30 days prior to study entry
* Agrees to use acceptable methods of contraception
Exclusion Criteria
* History of CD4 cell count less than 250 cells/mm3, opportunistic infections, or AIDS-defining illnesses. Patients who have had one CD4 count less than 250 cells/mm3 or who have had CD4 counts less than 250 cells/mm3 for not more than 2 weeks during acute infection are not excluded.
* History of autoimmune disease, immunodeficiency, asthma, diabetes requiring insulin or oral hypoglycemics, thyroid disease, bleeding disorder, active malignancy, viral hepatitis, or asplenia
* Positive HBV, HCV, or syphilis test
* Suspected allergy or adverse reaction to any component of the study agent
* Changes in antiretroviral regimen within 6 months prior to entry due to virologic failure (not including toxicities)
* Previous participation in STIs
* Pregnancy or breast-feeding
* Live attenuated vaccines or investigational research agents within the 30 days prior to study entry
* Blood products within the 120 days prior to study entry
* Immunoglobulin within the 60 days prior to study entry
* Subunit or killed vaccines or allergy treatments with antigen injections within the 14 days prior to study entry
* Prior experimental HIV vaccines
* Certain immunosuppressive medications within the 6 months prior to study entry
* Current TB prophylaxis or therapy
* Active drug or alcohol use or dependence that, in the opinion of the investigator, would interfere with adherence to study requirements
* Serious illness requiring systemic treatment and/or hospitalization. An individual who has either completed therapy OR is clinically stable for at least 14 days prior to study entry is eligible.
* Anti-dsDNA antibody greater than the upper limit of normal
18 Years
50 Years
ALL
No
Sponsors
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National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Principal Investigators
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Dan H. Barouch, MD, PhD
Role: STUDY_CHAIR
Beth Israel Deaconess Medical Center, Division of Viral Pathogenesis
Eric S. Rosenberg, MD
Role: STUDY_CHAIR
Massachusetts General Hospital, Division of Infectious Diseases
Locations
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Ucsd, Avrc Crs
San Diego, California, United States
Massachusetts General Hospital ACTG CRS
Boston, Massachusetts, United States
Brigham and Women's Hosp. ACTG CRS
Boston, Massachusetts, United States
Aaron Diamond AIDS Research Ctr. AIEDRP
New York, New York, United States
UW Primary Infection Clinic CRS
Seattle, Washington, United States
Countries
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References
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Altfeld M, Rosenberg ES, Shankarappa R, Mukherjee JS, Hecht FM, Eldridge RL, Addo MM, Poon SH, Phillips MN, Robbins GK, Sax PE, Boswell S, Kahn JO, Brander C, Goulder PJ, Levy JA, Mullins JI, Walker BD. Cellular immune responses and viral diversity in individuals treated during acute and early HIV-1 infection. J Exp Med. 2001 Jan 15;193(2):169-80. doi: 10.1084/jem.193.2.169.
Rosenberg ES, Altfeld M, Poon SH, Phillips MN, Wilkes BM, Eldridge RL, Robbins GK, D'Aquila RT, Goulder PJ, Walker BD. Immune control of HIV-1 after early treatment of acute infection. Nature. 2000 Sep 28;407(6803):523-6. doi: 10.1038/35035103.
Rosenberg ES, Graham BS, Chan ES, Bosch RJ, Stocker V, Maenza J, Markowitz M, Little S, Sax PE, Collier AC, Nabel G, Saindon S, Flynn T, Kuritzkes D, Barouch DH; AIDS Clinical Trials Group A5187 Team. Safety and immunogenicity of therapeutic DNA vaccination in individuals treated with antiretroviral therapy during acute/early HIV-1 infection. PLoS One. 2010 May 10;5(5):e10555. doi: 10.1371/journal.pone.0010555.
Other Identifiers
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10010
Identifier Type: REGISTRY
Identifier Source: secondary_id
ACTG A5187
Identifier Type: -
Identifier Source: secondary_id
A5187
Identifier Type: -
Identifier Source: org_study_id