Therapeutic Intensification Plus Immunomodulation to Decrease the HIV-1 Viral Reservoir (EraMune02)
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ClinicalTrials.gov Identifier: NCT00976404 |
Recruitment Status
:
Completed
First Posted
: September 14, 2009
Results First Posted
: September 12, 2014
Last Update Posted
: September 12, 2014
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Sponsor:
Robert L. Murphy
Collaborators:
Objectif Recherche Vaccins SIDA
National Institute of Allergy and Infectious Diseases (NIAID)
Pfizer
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Robert L. Murphy, Northwestern University
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Tracking Information | ||||
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First Submitted Date ICMJE | September 9, 2009 | |||
First Posted Date ICMJE | September 14, 2009 | |||
Results First Submitted Date | September 4, 2014 | |||
Results First Posted Date | September 12, 2014 | |||
Last Update Posted Date | September 12, 2014 | |||
Study Start Date ICMJE | November 2009 | |||
Actual Primary Completion Date | July 2013 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Change From Baseline in HIV DNA in PBMCs at Week 56 [ Time Frame: 56 weeks ] | |||
Original Primary Outcome Measures ICMJE |
HIV proviral DNA [ Time Frame: 56 weeks ] | |||
Change History | Complete list of historical versions of study NCT00976404 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Outcome Measures ICMJE | Not Provided | |||
Original Other Outcome Measures ICMJE | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Therapeutic Intensification Plus Immunomodulation to Decrease the HIV-1 Viral Reservoir | |||
Official Title ICMJE | Multicenter, Randomized, Non-comparative, Controlled Study of Therapeutic Intensification Plus Immunomodulation in HIV-infected Patients With Long-term Viral Suppression | |||
Brief Summary | The objective of this study is to discover a new approach in which human immunodeficiency virus (HIV) can be eradicated from an infected individual by intensified antiretroviral treatment coupled with immunomodulation. The hypothesis is that eradication is possible only if very potent antiretroviral drugs are delivered in conjunction with an immunomodulatory agent that simultaneously attack the viral reservoirs. | |||
Detailed Description | The objective of this study is to measure the impact of immunomodulation plus treatment intensification on the HIV reservoir in HIV-infected patients who have viral suppression on combination antiretroviral therapy. Treatment regimens first will be intensified by the addition of raltegravir and maraviroc for 8 week followed by immunomodulation with the NIH HIV-rAd5 vaccine plus DNA prime-boost for 24 weeks. The primary endpoint is measurement of change in peripheral cellular HIV DNA. A decrease of 0.5 log is considered significant. A secondary endpoints include change in HIV DNA in the rectal mucosa, immunologic changes in the peripheral blood and safety. | |||
Study Type ICMJE | Interventional | |||
Study Phase | Phase 2 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | HIV Infection | |||
Intervention ICMJE |
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Study Arms |
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Publications * | Achenbach CJ, Assoumou L, Deeks SG, Wilkin TJ, Berzins B, Casazza JP, Lambert-Niclot S, Koup RA, Costagliola D, Calvez V, Katlama C, Autran B, Murphy RL; EraMune 02 study team. Effect of therapeutic intensification followed by HIV DNA prime and rAd5 boost vaccination on HIV-specific immunity and HIV reservoir (EraMune 02): a multicentre randomised clinical trial. Lancet HIV. 2015 Mar;2(3):e82-91. doi: 10.1016/S2352-3018(15)00026-0. Epub 2015 Feb 17. | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
28 | |||
Original Estimated Enrollment ICMJE | Same as current | |||
Actual Study Completion Date | June 2014 | |||
Actual Primary Completion Date | July 2013 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years to 70 Years (Adult, Senior) | |||
Accepts Healthy Volunteers | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00976404 | |||
Other Study ID Numbers ICMJE | EraMune02 | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Robert L. Murphy, Northwestern University | |||
Study Sponsor ICMJE | Robert L. Murphy | |||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | Northwestern University | |||
Verification Date | September 2014 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |