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

Primary Purpose

Human Immunodeficiency Virus, Lipohypertrophy

Status

Terminated

Phase

Phase 2

Locations

France

Study Type

Interventional

Intervention

Raltegravir-Maraviroc

About this trial

This is an interventional treatment trial for Human Immunodeficiency Virus focused on measuring HIV, Lipohypertrophy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Hôpital Pitié Salpétrière

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Raltegravir-Maraviroc

Arm Description

Raltegravir 400 mg twice a day + Maraviroc 300 mg twice a day

Outcomes

Primary Outcome Measures

Virological failure

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

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

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

• Assessment of compliance conducted at screening and at W24 and 48.

Quality of life

• Assessment of health-related quality of life conducted at baseline and at W24 and 48.

Full Information

NCT ID

NCT01420523

First Posted

August 18, 2011

Last Updated

July 23, 2015

Sponsor

ANRS, Emerging Infectious Diseases

Collaborators

Merck Sharp & Dohme LLC, ViiV Healthcare

1. Study Identification

Unique Protocol Identification Number

NCT01420523

Brief Title

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

Acronym

ROCnRAL

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 Type

Interventional

2. Study Status

Record Verification Date

July 2015

Overall Recruitment Status

Terminated

Study Start Date

December 2011 (undefined)

Primary Completion Date

April 2013 (Actual)

Study Completion Date

April 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

ANRS, Emerging Infectious Diseases

Collaborators

Merck Sharp & Dohme LLC, ViiV Healthcare

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Human Immunodeficiency Virus, Lipohypertrophy

Keywords

HIV, Lipohypertrophy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

48 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Raltegravir-Maraviroc

Arm Type

Experimental

Arm Description

Raltegravir 400 mg twice a day + Maraviroc 300 mg twice a day

Intervention Type

Drug

Intervention Name(s)

Raltegravir-Maraviroc

Other Intervention Name(s)

Isentress and Celsentri

Intervention Description

Raltegravir 400 mg twice a day + Maraviroc 300 mg twice a day

Primary Outcome Measure Information:

Title

Virological failure

Description

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.

Time Frame

Week 24

Secondary Outcome Measure Information:

Title

Viro-immunological efficacy

Description

Time Frame

Between baseline and W48

Title

Tolerability criteria and metabolic impact

Description

Time Frame

Between baseline and W48

Title

Compliance

Description

• Assessment of compliance conducted at screening and at W24 and 48.

Time Frame

Between baseline and W48

Title

Quality of life

Description

• Assessment of health-related quality of life conducted at baseline and at W24 and 48.

Time Frame

Between baseline and W48

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Christine Katlama, MD

Organizational Affiliation

Groupe hospitalier Pitié-Salpétrière

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Dominique Costagliola

Organizational Affiliation

Inserm U943

Official's Role

Study Director

Facility Information:

Facility Name

Hôpital Pitié Salpétrière

City

Paris

ZIP/Postal Code

75013

Country

France

12. IPD Sharing Statement

Citations:

PubMed Identifier

26396157

Citation

Soulie C, Assoumou L, Darty M, Rodriguez C, Donati F, Sayon S, Peytavin G, Valantin MA, Caby F, Schneider L, Canestri A, Costagliola D, Katlama C, Calvez V, Marcelin AG; ROCnRAL ANRS-157 Study Group. Virological factors associated with outcome of dual maraviroc/raltegravir therapy (ANRS-157 trial). J Antimicrob Chemother. 2015 Dec;70(12):3339-44. doi: 10.1093/jac/dkv280. Epub 2015 Sep 22.

Results Reference

derived

PubMed Identifier

24535278

Citation

Katlama C, Assoumou L, Valantin MA, Soulie C, Duvivier C, Chablais L, Kolta S, Pialoux G, Mercie P, Simon A, Costagliola D, Peytavin G, Marcelin AG; ROCnRAL ANRS 157 Study Group. Maraviroc plus raltegravir failed to maintain virological suppression in HIV-infected patients with lipohypertrophy: results from the ROCnRAL ANRS 157 study. J Antimicrob Chemother. 2014 Jun;69(6):1648-52. doi: 10.1093/jac/dkt536. Epub 2014 Feb 16.

Results Reference

derived

Links:

URL

http://www.anrs.fr

Description

Related Info

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

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