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AzTrials

HIV InfectionPhase 2EraMune02NCT00976404

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

A Phase 2 study testing DNA + HIV-rAd5 vaccine, ART intensification (raltegravir) and ART intensification (maraviroc) in people with HIV Infection, run by Robert L. Murphy at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
HIV Infection
What is being tested?
DNA + HIV-rAd5 vaccine, ART intensification (raltegravir) and ART intensification (maraviroc)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
28 participants
Where
3 sitesUnited States
Study dates
Nov 2009to Jun 2014
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
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  • 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

Who cannot join

  • 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.
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  • 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

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • Northwestern University

    Chicago, Illinois, 60611

  • Cornell University

    New York, New York, 10011

  • University of California San Francisco

    San Francisco, California, 94110

Other trials in United States

About this study

Official title: Multicenter, Randomized, Non-comparative, Controlled Study of Therapeutic Intensification Plus Immunomodulation in HIV-infected Patients With Long-term Viral Suppression

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.

Read the 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.

Conditions
HIV Infection
Being tested
DNA + HIV-rAd5 vaccine, ART intensification (raltegravir), ART intensification (maraviroc)
Keywords
HIV-1 infection, Treatment intensification, Immunomodulation, HIV-rAd5 vaccine
Medical subject headings
HIV Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DNA + HIV-rAd5 vaccineBiological

    4 mg subcutaneous injection at weeks 8 (DNA prime), 12 (DNA prime), 16 (DNA prime), and 32 (HIV-rAd5)

  • ART intensification (raltegravir)Drug

    Also called Isentress

    raltegravir 400 mg PO BID for 56 weeks

  • ART intensification (maraviroc)Drug

    Also called Selzentry, Celsentri

    maraviroc 150, 300, or 600 mg PO BID (depending on PK interactions with other medications) for 56 weeks

Study groups in NCT00976404
Study groupRoleWhat they receive
Maraviroc + raltegravir intensificationActive comparatorART Intensification (addition of raltegravir and maraviroc to suppressive ART for 56 weeks)
Receives: Drug: ART intensification (raltegravir); Drug: ART intensification (maraviroc)
Maraviroc + raltegravir intens. plus DNA + HIV-rAd5 vaccineExperimentalART 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)
Receives: Biological: DNA + HIV-rAd5 vaccine; Drug: ART intensification (raltegravir); Drug: ART intensification (maraviroc)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change From Baseline in HIV DNA in PBMCs at Week 56

    Measured: 56 weeks

Secondary outcomes (4)

  1. Change From Baseline in HIV DNA in Rectal Tissue at Week 56

    Measured: Week 56

  2. Change From Baseline in CD4+ T Cell Count at Week 56

    Measured: Week 56

  3. HIV Specific T-cell Response to Env

    HIV-specific immunity: Interferon gamma ELISpot response to Env (clades A) at week 36 (one month after rAd5 boosting)

    Measured: 36 weeks

  4. Serious Adverse Events Attributed to Study Treatments

    Grade 3 or 4 serious adverse events related to study treatments (raltegravir, maraviroc, or HIV-recombinant Ad5-based vaccine)

    Measured: 56 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Sep 2009 (estimated)
  2. Study startNov 2009
  3. Primary completionJul 2013
  4. Study completionJun 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
28 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00976404
Sponsor's protocol ID
EraMune02
Acronym
EraMune02
Status last verified
Sep 2014
First submitted
9 Sep 2009
Last updated
12 Sep 2014
Data monitoring committee
Yes

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.

    PubMed 26424549

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing DNA + HIV-rAd5 vaccine, ART intensification (raltegravir) and ART intensification (maraviroc) in people with HIV Infection, run by Robert L. Murphy at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Sep 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in HIV DNA in PBMCs at Week 56 (time frame: 56 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00976404, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2014.

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