Text Size

Evaluation of Raltegravir Plus Maraviroc Therapy in Controlled HIV Patients Presenting With Lipohypertrophy (ROCnRAL)

This study is currently recruiting participants.
Verified April 2012 by French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
Sponsor:
Collaborators:
Merck
ViiV Healthcare
Information provided by (Responsible Party):
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
ClinicalTrials.gov Identifier:
NCT01420523
First received: August 18, 2011
Last updated: April 13, 2012
Last verified: April 2012
History of Changes
  Purpose

Evaluation of antiretroviral therapy combining Raltegravir and Maraviroc in patients with virological success, presenting with clinical lipohypertrophy.


Condition Intervention Phase
Human Immunodeficiency Virus
Lipohypertrophy
 Drug: Raltegravir-Maraviroc
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Pilot Study Evaluating the Efficacy of Dual Therapy With Raltegravir Plus Maraviroc in Patients Receiving Suppressive Antiretroviral Therapy and Presenting With Lipohypertrophy (ANRS 157 ROCnRAL).

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Further study details as provided by French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS):

Primary Outcome Measures:
  • Virological failure [ Time Frame: Week 24 ] [ Designated as safety issue: Yes ]
    Occurrence of virological failure, as verified by 2 consecutive plasma viral load measurements > 50 copies/mL, taken 2 to 4 weeks apart at most, during the first 24 weeks.


Secondary Outcome Measures:
  • Viro-immunological efficacy [ Time Frame: Between baseline and W48 ] [ Designated as safety issue: Yes ]
    • Proportion of patients with a HIV RNA viral load < 50 copies/mL.
    • Proportion of patients discontinuing the therapy:
    • Plasma genotypic resistance profile where the viral load is > 50 copies/mL.
    • Evaluation of DNA/RNA tropism in the event of failure.
    • Evaluation of plasma HIV RNA where the viral load is < 50 copies/mL, through ultrasensitive PCR testing.
    • Evolution of the CD4 and CD8 T-cell counts.
    • Blood concentration of raltegravir and maraviroc.

  • Tolerability criteria and metabolic impact [ Time Frame: Between baseline and W48 ] [ Designated as safety issue: No ]
    • Changes in glucose and lipid balance.
    • Changes in anthropometric measurements.
    • Number and severity of clinical and biological adverse effects.
    • Changes in bone mineral density and body composition, as measured by DEXA scan.
    • Changes in inflammation and endothelial activation markers between baseline and W48
    • Measurement of fat cells differentiation markers in adipose tissue biopsy samples

  • Compliance [ Time Frame: Between baseline and W48 ] [ Designated as safety issue: No ]
    • Assessment of compliance conducted at screening and at W24 and 48.

  • Quality of life [ Time Frame: Between baseline and W48 ] [ Designated as safety issue: No ]
    • Assessment of health-related quality of life conducted at baseline and at W24 and 48.


Estimated Enrollment: 90
Study Start Date: December 2011
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Raltegravir-Maraviroc
Raltegravir 400 mg twice a day + Maraviroc 300 mg twice a day
 Drug: Raltegravir-Maraviroc
Raltegravir 400 mg twice a day + Maraviroc 300 mg twice a day
Other Name: Isentress and Celsentri

Detailed Description:

Assess the ability to maintain the plasma HIV viral load below the threshold needed for detection (< 50 copies/mL) at 24 weeks of raltegravir/maraviroc therapy without NRTIs and PIs, in patients with virological success and presenting with clinical lipohypertrophy.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients infected with HIV-1 type B or CRF02.
  • ≥ 18 years old
  • Patients who have been receiving antiretroviral therapy for at least 5 years, and whose treatment has been stable for at least 6 months.
  • Patients whose plasma viral load has been undetectable (below 200 copies/mL) over the last 24 months, and < 50 copies/mL for at least 12 months.
  • Patients with an R5* tropic virus, as determined through DNA and with CD4 nadir ≥ 100/mm3 OR Patients with an R5 tropic virus as determined through DNA and determined through RNA of the last detectable viral load, irrespective of CD4 load.
  • Patients presenting with clinical lipohypertrophy recognized by themselves and by their doctors, and defined by increased volume of the abdominal and/or thoracic and/or cervical area (buffalo hump).
  • Patients who have never been treated with raltegravir.
  • Patients who have never been treated with maraviroc.
  • Efficient contraception for women
  • Free and informed written consent, signed by the patient and the investigator.
  • Patients with health insurance. * To increase the certainty of selecting patients with an R5 virus, the HIV-1 tropism will be determined by the genotype method and interpreted with the Geno2pheno[coreceptor] algorithm and a false positive rate threshold for X4 virus at 20%, rather than the usual 10%.

Exclusion Criteria:

  • X4, X4/5 or undetermined tropism of the HIV virus.
  • HIV-2 or coinfection HIV-1/HIV-2.
  • Chronic viral hepatitis B.
  • Chronic viral hepatitis C requiring specific treatment over the first 24 weeks.
  • Treatment with growth hormones.
  • Hypolipemic or diabetes treatment, begun within the last 3 months.
  • Pregnant or breastfeeding women.
  • Haemoglobin < 7g/dl, neutrophils < 500/mm3, platelets < 50 000/mm3, creatinine clearance < 50 mL/min, alkaline phosphatases, ASAT, ALAT or bilirubin ≥ 3 times the upper limit of the normal range (N).
  • Antiretroviral treatment associated to enzymatic inducer.
  • Chronic alcohol consumption.
  • Subjects under "sauvegarde de justice" (judicial protection due to temporarily and slightly diminished mental or physical faculties), or under legal guardianship.
  • Subjects participating in another clinical trial evaluating different therapies and including an exclusion period that is still in force during the screening phase.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01420523

Contacts
Contact: Christine Katlama, MD 33142160142 christine.katlama@psl.aphp.fr
Contact: Laetitia Chablais 33142164259 lchablais@ccde.chups.jussieu.fr

Locations
France
Hôpital Pitié Salpétrière Recruiting
Paris, France, 75013
Contact: Christine Katlama, MD     33142160142        
Principal Investigator: Christine Katlama            
Sponsors and Collaborators
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
Merck
ViiV Healthcare
Investigators
Principal Investigator: Christine Katlama, MD Groupe hospitalier Pitié-Salpétrière
Study Director: Dominique Costagliola Inserm U943
  More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
ClinicalTrials.gov Identifier: NCT01420523     History of Changes
Other Study ID Numbers: 2011-002483-24
Study First Received: August 18, 2011
Last Updated: April 13, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS):
HIV
Lipohypertrophy

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immunologic Deficiency Syndromes
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
 Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on March 07, 2013