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

NCT01420523 | Terminated Phase 2 DMC

• 2 other identifiers: ANRS 157 ROCnRAL2011-002483-24
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Human Immunodeficiency Virus; Lipohypertrophy

Keywords

HIV; Lipohypertrophy

Outcome Measures

Primary Outcomes (1)

• 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.

  Week 24

Secondary Outcomes (4)

• Viro-immunological efficacy

  Between baseline and W48

• Tolerability criteria and metabolic impact

  Between baseline and W48

• Compliance

  Between baseline and W48

• Quality of life

  Between baseline and W48

Study Arms (1)

Raltegravir-Maraviroc

EXPERIMENTAL

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

Drug: Raltegravir-Maraviroc

Interventions

Raltegravir-Maraviroc DRUG

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

Also known as: Isentress and Celsentri

Raltegravir-Maraviroc

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%.

You may not qualify if:

• 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.

Sponsors & Collaborators

• ANRS, Emerging Infectious Diseases: lead
• Merck Sharp & Dohme LLC: collaborator
• ViiV Healthcare: collaborator

Study Sites (1)

Hôpital Pitié Salpétrière

Paris, 75013, France

Location

Related Publications (2)

• 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.

  PMID: 26396157 DERIVED

• 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.

  PMID: 24535278 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Interventions

Raltegravir Potassium; Maraviroc

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pyrrolidinones; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Triazoles; Azoles

Study Officials

• Christine Katlama, MD

  Groupe hospitalier Pitié-Salpétrière

  PRINCIPAL INVESTIGATOR

• Dominique Costagliola

  Inserm U943

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2011
• First Posted: August 19, 2011
• Study Start: December 1, 2011
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2013
• Last Updated: April 2, 2026

Record last verified: 2026-04

Locations

FR (1)