Overview

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

Status:
Terminated
Trial end date:
2013-04-01
Target enrollment:
0
Participant gender:
All
Summary
Evaluation of antiretroviral therapy combining Raltegravir and Maraviroc in patients with virological success, presenting with clinical lipohypertrophy.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
ANRS, Emerging Infectious Diseases
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
Treatments:
Maraviroc
Raltegravir Potassium
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.