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Completed

NCT Number: NCT00944541

Evaluation of Maraviroc Intensification in HIV Infected Patients With Insufficient Immune Restoration

This pilot study aims to evaluate Maraviroc intensification strategy during 24 weeks in HIV infected patients under efficient (CV< 50 cp/mL), controlled antiretroviral therapy (≥ 6 months) and uncompleted immune restoration (CD4<350 cells/mL and CD4 earning <100 cells/mL during last 24 months).

The study will include 60 patients whose follow up is carried out for 48 weeks. recruitment period will be maintained for 12 months.

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Key information

Conditions

HIV Infection Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

French National Agency for Research on AIDS and Viral Hepatits

Paris, 75013, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • HIV-1 infection
  • maraviroc-naives patients
  • CD4 less than 350 cells/mm3
  • viral load less than 50 cp/mL and CD4 earning less than 100 cells/mm3 during last 24 months

Exclusion criteria

  • HIV-2 infection
  • X4 tropism at inclusion
  • pregnancy and breast feeding
  • interferon, immunomodulatory drugs treatment or anti-HIV vaccines and chemotherapy
  • hypersensibility of peanut or soya

Treatment and study plan

Maraviroc

Drug

maraviroc 150 mg or 300 mg or 600 mg twice a day for 24 weeks

Other names: Celsentri

Primary outcomes

  1. Evaluation of maraviroc intensification during 24 weeks in HIV infected patients with insufficient immune restoration despite controlled viral load

    Time frame: immunologic benefit at week 24

Secondary outcomes

  1. Maraviroc efficacy at W24 (virological and immunological efficacy); Durability of maraviroc efficacy between W24 & W36; Cmin of maraviroc and other molecules at W4,12,24; Evaluation of the safety of maraviroc between W0 and W36.

    Time frame: immuno-virologic evolution between week 0 and week 36

Sponsors and collaborators

Lead sponsor

French National Agency for Research on AIDS and Viral Hepatitis

Other Gov

Collaborators

  • Pfizer

Registry information

Official study title

Pilot Study Evaluating Maraviroc (Celsentri®)Intensification Benefit in HIV Infected Patients Presenting Insufficient Immune Restoration Despite Controlled Viral Load With Antiretroviral Treatment. ANRS 145 MARIMUNO

Acronym: 145 MARIMUNO

Important dates

Study start
2009
Primary completion
2010
Study completion
2011
First posted
Jul 23, 2009
Registry last updated
Apr 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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