NCT01420523TerminatedPhase 2
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).
ANRS, Emerging Infectious Diseases1 site in 1 country48 target enrollmentStarted: December 2011Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Terminated
- Enrollment
- 48
- Locations
- 1
- Primary Endpoint
- Virological failure
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients infected with HIV-1 type B or CRF
- •≥ 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-
- •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.
Arms & Interventions
Raltegravir-Maraviroc
Experimental
Raltegravir 400 mg twice a day + Maraviroc 300 mg twice a day
Intervention: Raltegravir-Maraviroc (Drug)
Outcomes
Primary Outcomes
Virological failure
Time Frame: Week 24
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 Outcomes
- Viro-immunological efficacy(Between baseline and W48)
- Tolerability criteria and metabolic impact(Between baseline and W48)
- Quality of life(Between baseline and W48)
- Compliance(Between baseline and W48)
Investigators
Study Sites (1)
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