Immune Response to a Therapeutic HIV Vaccine Followed by Treatment Interruption in Patients With Acute or Recent HIV Infection
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
4 other identifiers
interventional
25
3 countries
23
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2 hiv-infections
Started Mar 2006
Typical duration for phase_2 hiv-infections
23 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 13, 2005
CompletedFirst Posted
Study publicly available on registry
September 16, 2005
CompletedStudy Start
First participant enrolled
March 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2010
CompletedNovember 1, 2021
October 1, 2021
1.4 years
September 13, 2005
October 28, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Average of log10 HIV-1 RNA viral load
At Weeks 58 and 63
Frequency of Grade 3 or 4 systemic adverse events, the occurrence of a severe or life-threatening injection site adverse event, or death
Throughout study
Secondary Outcomes (13)
Distribution of plasma HIV RNA viral load
At Weeks 63 and 87
Proportion of patients with controlled viremia and their respective distribution of plasma HIV RNA viral load
At Weeks 63 and 87
Mean viral burden, defined as time-averaged area under the log10 HIV-1 RNA viral load curve
At Weeks 63 and 87
HIV DNA levels
At Weeks 30, 38, 63, and 87
HIV-1 DNA levels
At Weeks 30, 38, 46, 50, 63, and 87
- +8 more secondary outcomes
Study Arms (2)
1
EXPERIMENTALParticipants will receive the MRKAd5 HIV-1 gag/pol/nef vaccine at study entry and on Weeks 4 and 26
2
PLACEBO COMPARATORParticipants will receive the MRKAd5 HIV-1 gag/pol/nef vaccine placebo at study entry and on Weeks 4 and 26
Interventions
Eligibility Criteria
You may qualify if:
- Initiated HAART within 30 days of an acute or recent HIV-1 infection diagnosis. More information on this criterion can be found in the protocol.
- 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
You may not qualify if:
- Virologic relapse, defined as 2 consecutive measurements of viral load of 500 copies/mL or more at least 7 days apart within 12 months of baseline visit
- 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
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (23)
Ucsd Aiedrp
San Diego, California, 92103, United States
Ucsf Aiedrp
San Francisco, California, 94110, United States
LA Biomedical Research Institute at Harbor-UCLA AIEDRP
Torrance, California, United States
Univ. of Colorado Health Sciences Ctr. AIEDRP
Denver, Colorado, 80220, United States
Fenway Community Health Ctr. CRS
Boston, Massachusetts, 02115, United States
Washington U CRS
St Louis, Missouri, 63110, United States
Beth Israel Med. Ctr., ACTU
New York, New York, 10003, United States
Aaron Diamond AIDS Research Ctr. AIEDRP
New York, New York, 10016, United States
Unc Aids Crs
Chapel Hill, North Carolina, 27514, United States
UNC, Chapel Hill AIEDRP
Chapel Hill, North Carolina, 27599, United States
Duke Univ. Med. Ctr. Adult CRS
Durham, North Carolina, 27710, United States
Dumc Aiedrp
Durham, North Carolina, United States
The Miriam Hosp. ACTG CRS
Providence, Rhode Island, 02906, United States
407 Doctors CRS
Surry Hills, New South Wales, 2010, American Samoa
Holdsworth House Medical Practice CRS
Darlinghurst, New South Wales, 2010, Australia
St. Vincent's Hospital CRS
Darlinghurst, New South Wales, 2010, Australia
Taylor Square Private Clinic CRS
Darlinghurst, New South Wales, 2010, Australia
AIDS Research Initiative, Darlinghurst CRS
Darlinghurst, New South Wales, Australia
407 Doctors (Australia) AIEDRP
Sydney, 2010, Australia
AIDS Research Initiative (Australia) AIEDRP
Sydney, 2010, Australia
St. Vincent's Hosp. (Australia) AIEDRP
Sydney, 2010, Australia
Taylor Square Private Clinic (Australia) AIEDRP
Sydney, 2010, Australia
Holdsworth House Gen. Practice (Australia) AIEDRP
Sydney, Australia
Related Publications (4)
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.
PMID: 12195350BACKGROUNDMoss 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.
PMID: 12559781BACKGROUNDPapasavvas 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.
PMID: 10950770BACKGROUNDRosenberg 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.
PMID: 11029005BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- 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
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 13, 2005
First Posted
September 16, 2005
Study Start
March 1, 2006
Primary Completion
August 1, 2007
Study Completion
October 1, 2010
Last Updated
November 1, 2021
Record last verified: 2021-10