Controlling Acute or Early HIV Infection With Antiretroviral Drugs, Without a Candidate Vaccine.As Reported Previously, the Candidate Vaccie Was Not Provided by the Maufacturer as Promised
NCT ID: NCT00238459
Last Updated: 2013-11-20
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
58 participants
OBSERVATIONAL
2005-07-31
2013-10-31
Brief Summary
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Detailed Description
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Participants will elect to start or not start ART at the start of this study. Those participants who choose not to begin ART will not receive any intervention during this study but will be followed for the entire length of the study. Those participants that choose to begin ART will start taking study-approved ART in Step 1 of the study. Only patients who have a viral load of less than 50 copies/ml by Week 24 will proceed to Step 2; all other patients who begin ART will continue on study-approved ART but will not receive any vaccinations over the course of the study. Step 2 is the STI part of the study. In Step 2, patients will stop ART and will be randomly assigned to receive therapeutic vaccine or placebo injections at three timepoints: at the start of Step 2 and 12 and 24 weeks after starting Step 2. Injections will be given only to patients who have been on ART for at least 48 weeks; patients will receive their assigned injections 36 weeks after their first viral load reading of less than 50 copies/ml. A patient will enter Step 3 after having restarted ART for a minimum of 8 weeks after Step 2 ends, when the patient's viral load is less than 400 copies/ml and CD4 count is greater than 250 cells/ml. Entry into Step 4, which will include additional retreatment and revaccination, may be necessary for some participants, depending on individual immune response to the study-given ART and the injections.
The ART participants in this study will receive either study-provided ART or another approved ART; however, only study-provided ART will be provided by the study. Viral load and CD4 count will be closely monitored and will guide retreatment and revaccination as necessary. Blood collection will occur at all visits. A physical exam will occur at most visits. Urine collection and quality of life and adherence questionnaires will occur at selected visits.
NOTE: In August 2007 we were notified by the manufacturer of the candidate vaccine that they were no longer making the vaccine, and that the vaccine would no longer be available. Unfortunately too few participants have received either the vaccine or placebo to conclude anything about efficacy. No safety problems occurred.
Conditions
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Keywords
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Recently infected patients
Cohort 1)Patients elcted to be immediately treated with licensed drugs:21 patients Cohort 2) Or to delay treatment until clinically indicated:16 patieints
multiple licensed drugs not randomized
A vaccine,HIV-1 immunogen was not provided for evaluation
In the intial design, acandiate HIV vaccine was to be evaluated, but in August 2007 the manufacturer refused to provide vaccine to allow this study to evaluate the effect of a vaccine on control of HIV. Therefore the study became an observational study of the effects of early versus delayed initiation of antiretrovral therapy on the preservation of anti-HIV immune responses and the ability of patients to control virus after a closely monitored discontinuation of therapy.
Patients elected to take licensed drugs. The vaccine was not provided for evaluation
Note:In August 2007 we were notified by the manufacturer that the experimental vaccine was no longer being made and would no longer be available for this study. Too few participants have received the vaccine or placebo to conclude anything about potential efficacy
multiple licensed antiretroviral drugs; not randomized
Intended vaccine not provided, Licensed drugs provided, but were not investigated
Interventions
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Patients elected to take licensed drugs. The vaccine was not provided for evaluation
Note:In August 2007 we were notified by the manufacturer that the experimental vaccine was no longer being made and would no longer be available for this study. Too few participants have received the vaccine or placebo to conclude anything about potential efficacy
multiple licensed drugs not randomized
multiple licensed antiretroviral drugs; not randomized
Intended vaccine not provided, Licensed drugs provided, but were not investigated
Eligibility Criteria
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Inclusion Criteria
* ART naive
* Willing to use acceptable forms of contraception
Exclusion Criteria
* Currently involuntarily incarcerated
* Pregnant or breastfeeding
18 Years
65 Years
ALL
No
Sponsors
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National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Responsible Party
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Fred T. Valentine
Professor of Medicine
Principal Investigators
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Fred Valentine, MD
Role: PRINCIPAL_INVESTIGATOR
NYU Langone Health
Locations
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New York University School of Medicine
New York, New York, United States
McGill University and University of Montreal
Montreal, Quebec, Canada
Countries
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References
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Peters BS. The basis for HIV immunotherapeutic vaccines. Vaccine. 2001 Dec 12;20(5-6):688-705. doi: 10.1016/s0264-410x(01)00394-2.
Stekler J, Collier AC. Primary HIV Infection. Curr HIV/AIDS Rep. 2004 Jun;1(2):68-73. doi: 10.1007/s11904-004-0010-2.
Wahren B, Liu M. Therapeutic vaccination against HIV. Expert Rev Vaccines. 2004 Aug;3(4 Suppl):S179-88. doi: 10.1586/14760584.3.4.s179.
Related Links
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Click here for more information about the Center of AIDS Research at the New York University School of Medicine
Other Identifiers
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5P01AI57127-2
Identifier Type: -
Identifier Source: org_study_id