Evaluation of Raltegravir Plus Maraviroc Therapy in Controlled HIV Patients Presenting With Lipohypertrophy (ROCnRAL)
This study has been terminated.
Sponsor:
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 Posted: August 19, 2011
Last Update Posted: July 24, 2015
Collaborators:
Merck Sharp & Dohme Corp.
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)
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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 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). |
Resource links provided by NLM:
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 ]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 ]
- 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 ]
- 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 ]• Assessment of compliance conducted at screening and at W24 and 48.
- Quality of life [ Time Frame: Between baseline and W48 ]• Assessment of health-related quality of life conducted at baseline and at W24 and 48.
| Enrollment: | 48 |
| Study Start Date: | December 2011 |
| Study Completion Date: | April 2013 |
| 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
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| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| 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
- 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
Locations
| France | |
| 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
Investigators
| 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 Submitted: | August 18, 2011 |
| First Posted: | August 19, 2011 |
| 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):
|
HIV Lipohypertrophy |
Additional relevant MeSH terms:
|
Acquired Immunodeficiency Syndrome HIV Infections Immunologic Deficiency Syndromes Immune System Diseases Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Slow Virus Diseases |
Raltegravir Potassium Maraviroc 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 |