We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01420523
Recruitment Status : Terminated
First Posted : August 19, 2011
Last Update Posted : July 24, 2015
Information provided by (Responsible Party):

Study Description
Brief Summary:
Evaluation of antiretroviral therapy combining Raltegravir and Maraviroc in patients with virological success, presenting with clinical lipohypertrophy.

Condition or disease Intervention/treatment Phase
Human Immunodeficiency Virus Lipohypertrophy Drug: Raltegravir-Maraviroc Phase 2

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (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).
Study Start Date : December 2011
Primary Completion Date : April 2013
Study Completion Date : April 2013

Resource links provided by the National Library of Medicine

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

Arms and Interventions

Arm Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :
  1. Virological failure [ Time Frame: Week 24 ]
    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 :
  1. Viro-immunological efficacy [ Time Frame: Between baseline and W48 ]
    • 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.

  2. Tolerability criteria and metabolic impact [ Time Frame: Between baseline and W48 ]
    • 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

  3. Compliance [ Time Frame: Between baseline and W48 ]
    • Assessment of compliance conducted at screening and at W24 and 48.

  4. Quality of life [ Time Frame: Between baseline and W48 ]
    • Assessment of health-related quality of life conducted at baseline and at W24 and 48.

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01420523

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

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
First Posted: August 19, 2011    Key Record Dates
Last Update Posted: July 24, 2015
Last Verified: July 2015

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

Additional relevant MeSH terms:
Immunologic Deficiency Syndromes
Acquired Immunodeficiency Syndrome
HIV Infections
Immune System Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Raltegravir Potassium
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
HIV Integrase Inhibitors
Integrase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
CCR5 Receptor Antagonists