Immune Response to a Therapeutic HIV Vaccine Followed by Treatment Interruption in Patients With Acute or Recent HIV Infection
NCT ID: NCT00183261
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
PHASE2
25 participants
INTERVENTIONAL
2006-03-31
2010-10-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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1
Participants will receive the MRKAd5 HIV-1 gag/pol/nef vaccine at study entry and on Weeks 4 and 26
MRKAd5 HIV-1 gag/pol/nef
1.5 x 1010 Ad vg/mL, 1.0 mL administered intramuscularly
2
Participants will receive the MRKAd5 HIV-1 gag/pol/nef vaccine placebo at study entry and on Weeks 4 and 26
MRKAd5 HIV-1 gag/pol/nef placebo
1.0 mL administered intramuscularly
Interventions
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MRKAd5 HIV-1 gag/pol/nef
1.5 x 1010 Ad vg/mL, 1.0 mL administered intramuscularly
MRKAd5 HIV-1 gag/pol/nef placebo
1.0 mL administered intramuscularly
Eligibility Criteria
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Inclusion Criteria
* Initiated HAART within 30 days of documented acute or recent HIV-1 infection without interruption for more than 7 days
* Sustained viral suppression, defined as a viral load of 500 copies/mL or less 12 months prior to baseline with an undetectable HIV-1 RNA viral load between 60 to 7 days prior to baseline
* CD4 count of 450 cells/mm3 or more OR 35% or more between 60 to 14 days prior to baseline
* Ad5 neutralizing antibody titer of 200 or less at screening
* Willing to follow all study procedures and schedules
* Willing to interrupt HAART for at least 24 weeks following completion of the vaccination stage
* Negative for hepatitis B surface antigen (HBsAg) at screening
* Willing to use acceptable forms of contraception
* Infected with HIV-1 subtype B, if this information is available
Exclusion Criteria
* Received more than 7 days of continuous HAART other than that received within 16 days of acute or recent HIV-1 infection. Participants who received HAART as part of post-exposure prophylaxis (PEP) more than 6 months prior to the start of initial HAART may be eligible, provided that they did not acquire HIV-1 infection from the event that required PEP.
* History of anaphylaxis or allergy to vaccine components, including Tris buffer, magnesium chloride, and polysorbate 80 (Tween)
* History of clinically significant heart, lung, kidney, liver, pancreatic, gastrointestinal, or neurological disease that, in the opinion of the study investigator, may interfere with the study
* Contraindication to intramuscular (IM) injection, such as anticoagulant therapy or thrombocytopenia
* Receipt of any immune globulin or blood products within 3 months prior to baseline
* Receipt of any live vaccine within 30 days prior to baseline or any inactivated vaccine within 14 days prior to baseline
* Previous receipt of any HIV vaccine. Participants that were documented to have received only placebo are not excluded.
* History of any AIDS-defining illness. If a participant's sole AIDS-defining illness is Kaposi's sarcoma limited to the skin and is not anticipated to require systemic chemotherapy, that participant is not excluded.
* Currently receiving drugs or biologics not approved by the Food and Drug Administration (FDA) other than investigational HIV medications
* Current or past participation in other studies that might alter the participant's response to the study vaccination
* Use of any immunomodulatory agents, including but not limited to interleukin-2 (IL-2), granulocyte/macrophage-colony stimulating factor (GM-CSF), and systemic corticosteroids, within 30 days prior to baseline
* Active alcohol or substance use that, in the investigator's opinion, may interfere with the study
* Any other criteria or condition that, in the investigator's opinion, may interfere with the study
* Unwilling or unable to contribute to the planned peripheral blood mononuclear cell (PBMC) blood collection
* Pregnancy or breastfeeding
18 Years
55 Years
ALL
No
Sponsors
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Acute Infection and Early Disease Research Program
NETWORK
Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
NETWORK
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Responsible Party
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Principal Investigators
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Susan Little, MD
Role: STUDY_CHAIR
University of California, San Diego AIDS Vaccine Research Center
Douglas D. Richman, MD
Role: STUDY_CHAIR
Departments of Pathology and Medicine, University of California, San Diego
Locations
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Ucsd Aiedrp
San Diego, California, United States
Ucsf Aiedrp
San Francisco, California, United States
LA Biomedical Research Institute at Harbor-UCLA AIEDRP
Torrance, California, United States
Univ. of Colorado Health Sciences Ctr. AIEDRP
Denver, Colorado, United States
Fenway Community Health Ctr. CRS
Boston, Massachusetts, United States
Washington U CRS
St Louis, Missouri, United States
Beth Israel Med. Ctr., ACTU
New York, New York, United States
Aaron Diamond AIDS Research Ctr. AIEDRP
New York, New York, United States
Unc Aids Crs
Chapel Hill, North Carolina, United States
UNC, Chapel Hill AIEDRP
Chapel Hill, North Carolina, United States
Duke Univ. Med. Ctr. Adult CRS
Durham, North Carolina, United States
Dumc Aiedrp
Durham, North Carolina, United States
The Miriam Hosp. ACTG CRS
Providence, Rhode Island, United States
407 Doctors CRS
Surry Hills, New South Wales, American Samoa
Holdsworth House Medical Practice CRS
Darlinghurst, New South Wales, Australia
St. Vincent's Hospital CRS
Darlinghurst, New South Wales, Australia
Taylor Square Private Clinic CRS
Darlinghurst, New South Wales, Australia
AIDS Research Initiative, Darlinghurst CRS
Darlinghurst, New South Wales, Australia
407 Doctors (Australia) AIEDRP
Sydney, , Australia
AIDS Research Initiative (Australia) AIEDRP
Sydney, , Australia
St. Vincent's Hosp. (Australia) AIEDRP
Sydney, , Australia
Taylor Square Private Clinic (Australia) AIEDRP
Sydney, , Australia
Holdsworth House Gen. Practice (Australia) AIEDRP
Sydney, , Australia
Countries
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References
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Markowitz M, Jin X, Hurley A, Simon V, Ramratnam B, Louie M, Deschenes GR, Ramanathan M Jr, Barsoum S, Vanderhoeven J, He T, Chung C, Murray J, Perelson AS, Zhang L, Ho DD. Discontinuation of antiretroviral therapy commenced early during the course of human immunodeficiency virus type 1 infection, with or without adjunctive vaccination. J Infect Dis. 2002 Sep 1;186(5):634-43. doi: 10.1086/342559. Epub 2002 Aug 9.
Moss RB, Brandt C, Giermakowska WK, Savary JR, Theofan G, Zanetti M, Carlo DJ, Wallace MR. HIV-specific immunity during structured antiviral drug treatment interruption. Vaccine. 2003 Mar 7;21(11-12):1066-71. doi: 10.1016/s0264-410x(02)00610-2.
Papasavvas E, Ortiz GM, Gross R, Sun J, Moore EC, Heymann JJ, Moonis M, Sandberg JK, Drohan LA, Gallagher B, Shull J, Nixon DF, Kostman JR, Montaner LJ. Enhancement of human immunodeficiency virus type 1-specific CD4 and CD8 T cell responses in chronically infected persons after temporary treatment interruption. J Infect Dis. 2000 Sep;182(3):766-75. doi: 10.1086/315748. Epub 2000 Aug 17.
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.
Other Identifiers
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10025
Identifier Type: REGISTRY
Identifier Source: secondary_id
AIN504/ACTG A5218
Identifier Type: -
Identifier Source: secondary_id
AIN504-A5218
Identifier Type: -
Identifier Source: secondary_id
AIN504/A5218
Identifier Type: -
Identifier Source: org_study_id