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

ANRS, Emerging Infectious Diseases

Status and phase

Terminated

Phase 2

Conditions

Human Immunodeficiency Virus

Lipohypertrophy

Treatments

Drug: Raltegravir-Maraviroc

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01420523

2011-002483-24

Details and patient eligibility

About

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

Full 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.

Enrollment

48 patients

Sex

All

Ages

18+ years old

Volunteers

No 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.