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

Human Immunodeficiency Virus Clinical Trial

— 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).

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01420523
• Other study ID #: 2011-002483-24
• Status: Terminated
• Phase: Phase 2
• First received: August 18, 2011
• Last updated: July 23, 2015
• Start date: December 2011
• Est. completion date: April 2013

Study information

• Verified date: July 2015
• Source: French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 48
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• Human Immunodeficiency Virus
• Immunologic Deficiency Syndromes
• Lipohypertrophy

Intervention

Drug:
• Raltegravir-Maraviroc
Raltegravir 400 mg twice a day + Maraviroc 300 mg twice a day

Locations

Country	Name	City	State
France	Hôpital Pitié Salpétrière	Paris

Sponsors (3)

Lead Sponsor	Collaborator
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)	Merck Sharp & Dohme Corp., ViiV Healthcare

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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.	Between baseline and W48	Yes
Secondary	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	Between baseline and W48	No
Secondary	Compliance	• Assessment of compliance conducted at screening and at W24 and 48.	Between baseline and W48	No
Secondary	Quality of life	• Assessment of health-related quality of life conducted at baseline and at W24 and 48.	Between baseline and W48	No

External Links

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