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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
Sponsor:
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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition HIV Infection
Interventions Biological: DNA + HIV-rAd5 vaccine
Drug: ART intensification (raltegravir)
Drug: ART intensification (maraviroc)
Enrollment 28

Recruitment Details  
Pre-assignment Details  
Arm/Group Title ART Intensification: Maraviroc + Raltegravir Maraviroc + Raltegravir Plus DNA + HIV-rAd5 Vaccine
Hide Arm/Group Description ART Intensification (addition of raltegravir and maraviroc) to suppressive ART for 56 weeks 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)
Period Title: Overall Study
Started 14 14
Completed 14 14
Not Completed 0 0
Arm/Group Title ART Intensification: Maraviroc +Raltegravir Maraviroc + Raltegravir Plus DNA + HIV-rAd5 Vaccine Total
Hide Arm/Group Description ART Intensification (addition of raltegravir and maraviroc to suppressive ART for 56 weeks) 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 of all reporting groups
Overall Number of Baseline Participants 14 14 28
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 14 participants 14 participants 28 participants
49
(46 to 55)
50
(46 to 55)
50
(46 to 55)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 14 participants 28 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
14
 100.0%
14
 100.0%
28
 100.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 14 participants 28 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
3
  21.4%
3
  10.7%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
1
   7.1%
1
   7.1%
2
   7.1%
White
11
  78.6%
9
  64.3%
20
  71.4%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
2
  14.3%
1
   7.1%
3
  10.7%
CD4 cell count  
Median (Inter-Quartile Range)
Unit of measure:  Cells per mm^3
Number Analyzed 14 participants 14 participants 28 participants
686
(501 to 880)
563
(468 to 718)
636
(485 to 791)
Time on antiretroviral treatment (ART)  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 14 participants 14 participants 28 participants
13
(8 to 19)
13
(6 to 19)
13
(8 to 19)
Adenovirus 5 antibody   [1] 
Median (Inter-Quartile Range)
Unit of measure:  Titer
Number Analyzed 14 participants 14 participants 28 participants
18
(12 to 68)
12
(12 to 38)
12
(12 to 41)
[1]
Measure Description: Serum Ad5 90% neutralization antibody titer
HIV DNA  
Median (Inter-Quartile Range)
Unit of measure:  Copies per 10^6 PBMC
Number Analyzed 14 participants 14 participants 28 participants
97
(47 to 352)
228
(98 to 383)
170
(60 to 361)
1.Primary Outcome
Title Change From Baseline in HIV DNA in PBMCs at Week 56
Hide Description [Not Specified]
Time Frame 56 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title ART Intensification: Maraviroc +Raltegravir Maraviroc + Raltegravir Plus DNA + HIV-rAd5 Vaccine
Hide Arm/Group Description:
ART Intensification (addition of raltegravir and maraviroc to suppressive ART for 56 weeks)
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)
Overall Number of Participants Analyzed 14 14
Median (Inter-Quartile Range)
Unit of Measure: log^10 copies per 10^6 PBMCs
0.00
(-0.29 to 0.16)
0.04
(-0.11 to 0.19)
2.Secondary Outcome
Title Change From Baseline in HIV DNA in Rectal Tissue at Week 56
Hide Description [Not Specified]
Time Frame Week 56
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Maraviroc + Raltegravir Intensification Maraviroc + Raltegravir Intens. Plus DNA + HIV-rAd5 Vaccine
Hide Arm/Group Description:
ART Intensification (addition of raltegravir and maraviroc to suppressive ART for 56 weeks)
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)
Overall Number of Participants Analyzed 7 6
Median (Inter-Quartile Range)
Unit of Measure: log^10 copies per 10^6 cells
0.08
(-0.06 to 0.22)
-0.02
(-0.02 to 0.41)
3.Secondary Outcome
Title Change From Baseline in CD4+ T Cell Count at Week 56
Hide Description [Not Specified]
Time Frame Week 56
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Maraviroc + Raltegravir Intensification Maraviroc + Raltegravir Intens. Plus DNA + HIV-rAd5 Vaccine
Hide Arm/Group Description:
ART Intensification (addition of raltegravir and maraviroc to suppressive ART for 56 weeks)
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)
Overall Number of Participants Analyzed 14 14
Median (Inter-Quartile Range)
Unit of Measure: cells per mm^3
-1
(-144 to 151)
23
(-100 to 114)
4.Secondary Outcome
Title HIV Specific T-cell Response to Env
Hide Description HIV-specific immunity: Interferon gamma ELISpot response to Env (clades A) at week 36 (one month after rAd5 boosting)
Time Frame 36 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Maraviroc + Raltegravir Intensification Maraviroc + Raltegravir Intens. Plus DNA + HIV-rAd5 Vaccine
Hide Arm/Group Description:
ART Intensification (addition of raltegravir and maraviroc to suppressive ART for 56 weeks)
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)
Overall Number of Participants Analyzed 14 14
Median (Standard Deviation)
Unit of Measure: response per 10^6 PBMCs
28  (50) 86  (235)
5.Secondary Outcome
Title Serious Adverse Events Attributed to Study Treatments
Hide Description Grade 3 or 4 serious adverse events related to study treatments (raltegravir, maraviroc, or HIV-recombinant Ad5-based vaccine)
Time Frame 56 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Maraviroc + Raltegravir Intensification Maraviroc + Raltegravir Intens. Plus DNA + HIV-rAd5 Vaccine
Hide Arm/Group Description:
ART Intensification (addition of raltegravir and maraviroc to suppressive ART for 56 weeks)
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)
Overall Number of Participants Analyzed 14 14
Measure Type: Number
Unit of Measure: serious adverse events
1 3
Time Frame 56 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Maraviroc + Raltegravir Intensification Maraviroc + Raltegravir Intens. Plus DNA + HIV-rAd5 Vaccine
Hide Arm/Group Description ART Intensification (addition of raltegravir and maraviroc to suppressive ART for 56 weeks) 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)
All-Cause Mortality
Maraviroc + Raltegravir Intensification Maraviroc + Raltegravir Intens. Plus DNA + HIV-rAd5 Vaccine
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Maraviroc + Raltegravir Intensification Maraviroc + Raltegravir Intens. Plus DNA + HIV-rAd5 Vaccine
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/14 (7.14%)      3/14 (21.43%)    
Cardiac disorders     
acute coronary syndrome  [1]  0/14 (0.00%)  1/14 (7.14%)  1
Musculoskeletal and connective tissue disorders     
creatine kinase  [2]  1/14 (7.14%)  1 0/14 (0.00%)  0
Renal and urinary disorders     
Renal failure  [3]  0/14 (0.00%)  1/14 (7.14%)  1
Vascular disorders     
deep vein thrombosis * [4]  0/14 (0.00%)  1/14 (7.14%)  1
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
[1]
Grade 3 left arm, neck and chest pain
[2]
Grade 4 creatine kinase
[3]
Grade 4 acute renal failure, Grade 4 creatinine
[4]
Grade 3 deep vein thrombosis
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Maraviroc + Raltegravir Intensification Maraviroc + Raltegravir Intens. Plus DNA + HIV-rAd5 Vaccine
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/14 (0.00%)      0/14 (0.00%)    
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
Responsible Party: Robert L. Murphy, Northwestern University
ClinicalTrials.gov Identifier: NCT00976404     History of Changes
Other Study ID Numbers: EraMune02
First Submitted: September 9, 2009
First Posted: September 14, 2009
Results First Submitted: September 4, 2014
Results First Posted: September 12, 2014
Last Update Posted: September 12, 2014