Pilot Study of Maraviroc/Raltegravir for Naive HIV-1 Patients

• Register: ClinicalTrials.gov
• Last refreshed on: 18 January 2016
• Main ID: NCT01291459
• Date of registration: 26/01/2011
• Prospective Registration: Yes
• Primary sponsor: Association Pour la Recherche en Infectiologie
• Public title: Pilot Study of Maraviroc/Raltegravir for Naive HIV-1 Patients NNNB
• Scientific title: Phase II Pilot Study of Simplification to Maraviroc - Raltegravir Dual Therapy After 6 Months of Maraviroc - Raltegravir - Tenofovir - Emtricitabine Quadruple Therapy in ARV Treatment-naive, HIV-1-infected Patients With CCR5- Virus
• Date of first enrolment: September 2011
• Target sample size: 40
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/show/NCT01291459
• Study type: Interventional
• Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

France

Contacts

• Name: Laurent COTTE, MD

Key inclusion & exclusion criteria

Inclusion Criteria:

- Age = 18 years old at the run-in visit

- HIV-1 infection

- Antiretroviral treatment-naive

- CD4 = 200 /mm3

- HIV- RNA = 1000 copies/ml

- HIV-RNA = 100,000 copies/ml

- Antiretroviral therapy is indicated according to current guidelines

- CCR5-tropic virus according to the Trofile ES® assayGeno2Pheno algorithm using a
predefined false positive rate of 20%

- No significant NRTI, NNRTI or PI resistance mutation

- Freely-given, written, informed consent obtained; the patient and investigator have
signed the consent form (by the latest on the day of the run-in visit and before
performing any examinations required by the trial)

- Patient covered by a French national health insurance scheme

Exclusion Criteria:

- Women of child-bearing potential not using effective contraception (barrier method)

- Pregnant or breast-feeding women

- Patients under the age of 18 years

- Patients deprived of liberty by a judicial or administrative, hospitalized patients
without consent, patients admitted to a health or social purposes other than research

- Persons major subject of a measure of legal protection or unable to consent

- Previous antiretroviral therapy (with the exception of post-exposure prophylaxis if
HIV serology is negative > 3 months after the last dose of antiretroviral drugs)

- CXCR4-tropic virus, dual/mixed-tropic virus or undetermined tropism on screening

- Presence of significant NRTI, NNRTI or PI resistance mutation(s)

- Infection or co-infection with HIV-2, or group O or N HIV-1

- Acute phase of an opportunistic infection

- Undergoing treatment for tuberculosis

- Undergoing chemotherapy and/or radiotherapy for neoplastic disease

- Decompensated cirrhosis (Child-Pugh class B or C)

- HIV-HBV co-infection. Patients with HIV-HCV co-infection are permitted to participate
in the absence of decompensated cirrhosis (Child-Pugh class B or C), of
hepatocytolysis > 3 times the upper limit of normal and if treatment for HCV during
the ensuing 12 months is not indicated. PAtients with occult HBV are excluded.(
positive AcHBc, negative AcHBs, negative AgHBs, positive HBV DNA)

- Co-administration of prohibited treatments (see the SPCs of each product) Laboratory
parameters: Haemoglobin < 7g/dl, neutrophil count < 500/mm3, platelet count <
50,000/mm3, creatinine clearance < 50 ml/min, alkaline phosphatase, AST, ALT or
bilirubin = 3 times upper limit of normal

- Patient refuses to participate



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

HIV

Intervention(s)

Drug: MVC/RAL/FTC/TDF followed by Maraviroc/Raltegravir

Primary Outcome(s)

HIV-1 viral load [Time Frame: 48 weeks]

Secondary ID(s)

2009/HD/01

Source(s) of Monetary Support

Please refer to primary and secondary sponsors