Therapeutic Intensification Plus Immunomodulation to Decrease the HIV-1 Viral Reservoir (EraMune02)

This study has been completed.
Sponsor:
Collaborators:
Objectif Recherche Vaccins SIDA
Pfizer
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Robert L. Murphy, Northwestern University
ClinicalTrials.gov Identifier:
NCT00976404
First received: September 9, 2009
Last updated: September 10, 2014
Last verified: September 2014
Results First Received: September 4, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: HIV Infection
Interventions: Biological: DNA + HIV-rAd5 vaccine
Drug: ART intensification (raltegravir)
Drug: ART intensification (maraviroc)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
ART Intensification: Maraviroc + Raltegravir ART Intensification (addition of raltegravir and maraviroc) to suppressive ART for 56 weeks
Maraviroc + Raltegravir Plus DNA + HIV-rAd5 Vaccine ART Intensification (addition of raltegravir and maraviroc for 56 weeks) PLUS immunomodulation therapy with DNA prime vaccine (Weeks 8,12,16) + HIV-recombinant Ad5-based vaccine (Week 32)

Participant Flow:   Overall Study
    ART Intensification: Maraviroc + Raltegravir     Maraviroc + Raltegravir Plus DNA + HIV-rAd5 Vaccine  
STARTED     14     14  
COMPLETED     14     14  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
ART Intensification: Maraviroc +Raltegravir ART Intensification (addition of raltegravir and maraviroc to suppressive ART for 56 weeks)
Maraviroc + Raltegravir Plus DNA + HIV-rAd5 Vaccine ART Intensification (addition of raltegravir and maraviroc for 56 weeks) PLUS immunomodulation therapy with DNA prime vaccine (Weeks 8,12,16) + HIV-recombinant Ad5-based vaccine (Week 32)
Total Total of all reporting groups

Baseline Measures
    ART Intensification: Maraviroc +Raltegravir     Maraviroc + Raltegravir Plus DNA + HIV-rAd5 Vaccine     Total  
Number of Participants  
[units: participants]
  14     14     28  
Age  
[units: years]
Median ( Inter-Quartile Range )
  49  
  ( 46 to 55 )  
  50  
  ( 46 to 55 )  
  50  
  ( 46 to 55 )  
Gender  
[units: participants]
     
Female     0     0     0  
Male     14     14     28  
Race (NIH/OMB)  
[units: participants]
     
American Indian or Alaska Native     0     0     0  
Asian     0     3     3  
Native Hawaiian or Other Pacific Islander     0     0     0  
Black or African American     1     1     2  
White     11     9     20  
More than one race     0     0     0  
Unknown or Not Reported     2     1     3  
CD4 cell count  
[units: cells per mm^3]
Median ( Inter-Quartile Range )
  686  
  ( 501 to 880 )  
  563  
  ( 468 to 718 )  
  636  
  ( 485 to 791 )  
Time on antiretroviral treatment (ART)  
[units: years]
Median ( Inter-Quartile Range )
  13  
  ( 8 to 19 )  
  13  
  ( 6 to 19 )  
  13  
  ( 8 to 19 )  
Adenovirus 5 antibody [1]
[units: titer]
Median ( Inter-Quartile Range )
  18  
  ( 12 to 68 )  
  12  
  ( 12 to 38 )  
  12  
  ( 12 to 41 )  
HIV DNA  
[units: copies per 10^6 PBMC]
Median ( Inter-Quartile Range )
  97  
  ( 47 to 352 )  
  228  
  ( 98 to 383 )  
  170  
  ( 60 to 361 )  
[1] Serum Ad5 90% neutralization antibody titer



  Outcome Measures
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1.  Primary:   Change From Baseline in HIV DNA in PBMCs at Week 56   [ Time Frame: 56 weeks ]

2.  Secondary:   Change From Baseline in HIV DNA in Rectal Tissue at Week 56   [ Time Frame: Week 56 ]

3.  Secondary:   Change From Baseline in CD4+ T Cell Count at Week 56   [ Time Frame: Week 56 ]

4.  Secondary:   HIV Specific T-cell Response to Env   [ Time Frame: 36 weeks ]

5.  Secondary:   Serious Adverse Events Attributed to Study Treatments   [ Time Frame: 56 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Baiba Berzins, MPH
Organization: Northwestern University
phone: 312-695-5012
e-mail: baiba@northwestern.edu


No publications provided


Responsible Party: Robert L. Murphy, Northwestern University
ClinicalTrials.gov Identifier: NCT00976404     History of Changes
Other Study ID Numbers: EraMune02
Study First Received: September 9, 2009
Results First Received: September 4, 2014
Last Updated: September 10, 2014
Health Authority: United States: Food and Drug Administration