Therapeutic Intensification Plus Immunomodulation in HIV-infected Patients

NCT01019551

Last updated date
Study Location
Groupe Hospitalier Pitié-Salpêtrière
Paris, , 75013, France
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
HIV-1 Infection
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-70 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- HIV-1 infection, documented by any licensed ELISA test kit and confirmed by Western Blot at any time prior to study entry. HIV-1 culture, HIV-1 antigen, plasma HIV-1 RNA, or a second antibody test by a method other than ELISA is acceptable as an alternative confirmatory test

- 18 ≤ Age ≤ 70 years

- At least 3 years of suppressive ART without any interruption (less than one month cumulative),

- ART treatment 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 loads (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. Note: the assay used must have a lower limit of detection of 75 copies/ml or less

- CD4+ count ≥ 350 cells/mm3 within 60 days of entry

- 10 ≤ Proviral DNA ≤ 1000 copies/106 PBMCs within 60 days of entry

- Documented laboratory values: Haemoglobin ≥ 10 g/dl, Platelets ≥ 100,000 per microliter, Hepatic transaminases ≤ 2.5 x ULN, Creatinine clearance ≥ 50 ml/min by the Cockcroft-Gault equation

- All subjects must agree not to participate in the conception process (e.g. active attempt to become pregnant or to impregnate, sperm donation, in vitro fertilization), and if participating in sexual activity that could lead to pregnancy, the subject/partner must use at least two reliable forms of contraceptives (condoms, with or without spermicidal agent, a diaphragm or cervical cap with spermicide, an IUD, or hormone-based contraception), while receiving study treatment and for 6 weeks after stopping study treatment

- Ability and willingness to provide informed consent.

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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 as documented by a urine pregnancy test, or lactating women


- Hepatitis B antigen (HBsAg) positive


- Hepatitis C virus (HCV-Ab) 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 and toxicity switches is allowed, provided that 1) virologic
suppression was maintained before, during and after raltegravir treatment and 2) the
patient has not received raltegravir treatment in the 6 months prior to study entry.


- Previous immunologic therapeutic intervention (e.g. IL-2, IL-7) 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 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 center
investigator, would interfere with adherence to study requirements.

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Advanced Information
Descriptive Information
Brief Title  ICMJE Therapeutic Intensification Plus Immunomodulation in HIV-infected Patients
Official Title  ICMJE International, Multicenter, Randomized, Non-comparative Controlled Study of Therapeutic Intensification Plus Immunomodulation in HIV-infected Patients With Long-term Viral Suppression
Brief Summary Viral eradication in selected HIV-infected patients is possible with intensive antiretroviral therapy plus immunomodulation
Detailed Description

The overall strategy of the ERAMUNE 01 Trial is to treat selected patients with an optimal synergistic antiretroviral regimen plus one or more immunomodulating agents. Among immunomodulating treatments the candidates include therapies from two functional classes: 1) agents that target actively replicating cells and 2) agents activating latently infected cells31.

The novelty of this approach is three-fold: first, the use of highly potent antiretroviral therapy combining drugs with different HIV enzymes targets or receptors and different penetrations in cells, with the aim to suppress virus to truly undetectable levels as measured by the most sophisticated viral quantification techniques; secondly, the addition of an immunomodulatory therapy that specifically targets viral reservoirs to this intensification strategy; and lastly, the rigorous selection of patients having already a low HIV reservoir as measured by peripheral blood HIV DNA content. To our knowledge, this type of strategy has not been implemented. We believe this strategy is feasible.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE HIV-1 Infection
Intervention  ICMJE
  • Drug: ART Intensification
    Current ART regimen plus raltegravir and maraviroc Raltegravir : 400 mg PO BID for 56 weeks Maraviroc : 150, 300 or 600 mg PO BID depending on concomitant ART treatment, for 56 weeks
  • Biological: Immunomodulation
    Starting at Week 8, 1 cycle of 3 injections (1 per week) of recombinant human Interleukin-7 (r-hIL-7 / CYT107) at a 20 µg/kg dose.
Study Arms  ICMJE
  • Experimental: ARM A : ART intensification alone
    Raltegravir PO 400 mg BID Maraviroc PO 150, 300 or 600 mg BID depending on the concomitant ART regimen
    Intervention: Drug: ART Intensification
  • Experimental: ARM B : ART intensification + Immunomodulation
    Raltegravir PO 400 mg BID during 56 weeks Maraviroc PO 150, 300 or 600 mg BID depending on the concomitant ART regimen during 56 weeks 3 weekly injections of r-hIL-7 (CYT107) at a 20 micrograms/kg dose starting at Week 8
    Interventions:
    • Drug: ART Intensification
    • Biological: Immunomodulation
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 12, 2013)
29
Original Estimated Enrollment  ICMJE
 (submitted: November 24, 2009)
28
Actual Study Completion Date  ICMJE February 2013
Actual Primary Completion Date July 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • HIV-1 infection, documented by any licensed ELISA test kit and confirmed by Western Blot at any time prior to study entry. HIV-1 culture, HIV-1 antigen, plasma HIV-1 RNA, or a second antibody test by a method other than ELISA is acceptable as an alternative confirmatory test
  • 18 ? Age ? 70 years
  • At least 3 years of suppressive ART without any interruption (less than one month cumulative),
  • ART treatment 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 loads (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. Note: the assay used must have a lower limit of detection of 75 copies/ml or less
  • CD4+ count ? 350 cells/mm3 within 60 days of entry
  • 10 ? Proviral DNA ? 1000 copies/106 PBMCs within 60 days of entry
  • Documented laboratory values: Haemoglobin ? 10 g/dl, Platelets ? 100,000 per microliter, Hepatic transaminases ? 2.5 x ULN, Creatinine clearance ? 50 ml/min by the Cockcroft-Gault equation
  • All subjects must agree not to participate in the conception process (e.g. active attempt to become pregnant or to impregnate, sperm donation, in vitro fertilization), and if participating in sexual activity that could lead to pregnancy, the subject/partner must use at least two reliable forms of contraceptives (condoms, with or without spermicidal agent, a diaphragm or cervical cap with spermicide, an IUD, or hormone-based contraception), while receiving study treatment and for 6 weeks after stopping study treatment
  • Ability and willingness to provide informed consent.

Exclusion Criteria:

  • 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 as documented by a urine pregnancy test, or lactating women
  • Hepatitis B antigen (HBsAg) positive
  • Hepatitis C virus (HCV-Ab) 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 and toxicity switches is allowed, provided that 1) virologic suppression was maintained before, during and after raltegravir treatment and 2) the patient has not received raltegravir treatment in the 6 months prior to study entry.
  • Previous immunologic therapeutic intervention (e.g. IL-2, IL-7) 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 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 center investigator, would interfere with adherence to study requirements.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France,   Italy,   Spain,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01019551
Other Study ID Numbers  ICMJE ORVACS 010
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Objectif Recherche Vaccins SIDA
Study Sponsor  ICMJE Objectif Recherche Vaccins SIDA
Collaborators  ICMJE
  • Cytheris SA
  • Merck Sharp & Dohme Corp.
  • Pfizer
Investigators  ICMJE
Principal Investigator:Christine KATLAMA, MDGroupe Hospitalier Pitié-Salpêtrière
Study Chair:Steven DEEKS, MDUniversity of California, San Francisco
Study Director:François LECARDONNEL, MScORVACS
PRS Account Objectif Recherche Vaccins SIDA
Verification Date June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP