Therapeutic Intensification Plus Immunomodulation to Decrease the HIV-1 Viral Reservoir
EraMune02
Multicenter, Randomized, Non-comparative, Controlled Study of Therapeutic Intensification Plus Immunomodulation in HIV-infected Patients With Long-term Viral Suppression
1 other identifier
interventional
28
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Nov 2009
Typical duration for phase_2
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 9, 2009
CompletedFirst Posted
Study publicly available on registry
September 14, 2009
CompletedStudy Start
First participant enrolled
November 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2014
CompletedResults Posted
Study results publicly available
September 12, 2014
CompletedSeptember 12, 2014
September 1, 2014
3.7 years
September 9, 2009
September 4, 2014
September 10, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change From Baseline in HIV DNA in PBMCs at Week 56
56 weeks
Secondary Outcomes (4)
Change From Baseline in HIV DNA in Rectal Tissue at Week 56
Week 56
Change From Baseline in CD4+ T Cell Count at Week 56
Week 56
HIV Specific T-cell Response to Env
36 weeks
Serious Adverse Events Attributed to Study Treatments
56 weeks
Study Arms (2)
Maraviroc + raltegravir intensification
ACTIVE COMPARATORART Intensification (addition of raltegravir and maraviroc to suppressive ART for 56 weeks)
Maraviroc + raltegravir intens. plus DNA + HIV-rAd5 vaccine
EXPERIMENTALART 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)
Interventions
4 mg subcutaneous injection at weeks 8 (DNA prime), 12 (DNA prime), 16 (DNA prime), and 32 (HIV-rAd5)
raltegravir 400 mg PO BID for 56 weeks
maraviroc 150, 300, or 600 mg PO BID (depending on PK interactions with other medications) for 56 weeks
Eligibility Criteria
You may qualify if:
- HIV-1 infection
- At least 3 years of ART without interruption (less than one month cumulative)
- ART regimen unchanged in the 3 months prior to screening
- One HIV plasma viral load (RNA) documented at least 3 years prior to entry, and at least 2 HIV plasma viral load (RNA) documented per year thereafter
- HIV plasma viral load (RNA) ≤ 500 copies/mL at least 3 years prior to entry, and HIV plasma viral load \< 500 copies/mL for \>90% of the measures thereafter
- HIV plasma viral load (RNA) below the limit of detection for all values within the past year (one virologic blip allowed)
- HIV plasma viral load below the limit of detection within 60 days of entry
- CD4+ count ≥ 350 cells/mm3 within 60 days of entry
- Proviral DNA ≥10 and ≤1000 copies/106 PBMCs within 75 days of entry
- Adeno5 neutralizing antibody titers of 250 or less within 75 days of entry
- Hemoglobin ≥ 10 g/dL within 60 days of entry
- Platelets ≥ 100,000 per microliter within 60 days of entry
- Hepatic transaminases (ALT and AST) ≤ 2.5 x ULN within 60 days of entry
- Creatinine clearance \> 50 mL/min by the Cockcroft-Gault equation within 60 days of entry
You may not qualify if:
- Sexually active men and women who will not practice at least one form of barrier birth control (male partner using condoms, female partner using condoms, other barrier contraception, etc)
- Pregnancy
- Inability or unwillingness to provide informed consent
- HBsAg positive
- HCV antibody positive or HCV RNA detectable
- Previous use of an integrase inhibitor (ie raltegravir) or a CCR5 inhibitor (ie maraviroc, vicriviroc). Use of raltegravir for non-treatment failure indications such as intensification or toxicity switches is allowed.
- Immunologic therapeutic intervention (e.g. IL-2) within the past year
- Participation in another clinical drug or device trial where the last dose of drug was within the past 30 days or an investigational medical device is currently implanted
- Diagnosis of cancer within the last 5 years (except basal cell cutaneous cancers and cutaneous KS not requiring systemic therapy)
- Co-morbid condition with an expected survival of less than 12 months
- History of hypersensitivity to vaccination
- History of autoimmune disease, such as systemic lupus erythematosis (SLE) or Hashimoto's thyroiditis
- Active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Robert L. Murphylead
- Objectif Recherche Vaccins SIDAcollaborator
- National Institute of Allergy and Infectious Diseases (NIAID)collaborator
- Pfizercollaborator
- Merck Sharp & Dohme LLCcollaborator
Study Sites (3)
University of California San Francisco
San Francisco, California, 94110, United States
Northwestern University
Chicago, Illinois, 60611, United States
Cornell University
New York, New York, 10011, United States
Related Publications (1)
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.
PMID: 26424549DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Baiba Berzins, MPH
- Organization
- Northwestern University
Study Officials
- STUDY CHAIR
Robert Murphy, MD
Northwestern University
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
September 9, 2009
First Posted
September 14, 2009
Study Start
November 1, 2009
Primary Completion
July 1, 2013
Study Completion
June 1, 2014
Last Updated
September 12, 2014
Results First Posted
September 12, 2014
Record last verified: 2014-09