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)
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)
ClinicalTrials.gov Identifier:
NCT01420523
First received: August 18, 2011
Last updated: April 30, 2013
Last verified: April 2013
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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 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:
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.
| Enrollment: | 48 |
| Study Start Date: | December 2011 |
| Study Completion Date: | April 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
- 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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01420523
Please refer to this study by its ClinicalTrials.gov identifier: 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:
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 30, 2013 |
| 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 Immune System Diseases Immunologic Deficiency Syndromes Lentivirus Infections RNA Virus Infections |
Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Virus Diseases |
ClinicalTrials.gov processed this record on February 27, 2015