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

HIV Infections Clinical Trial

— 145 MARIMUNO  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00944541
• Other study ID #: 2009-011171-76
• Secondary ID: ANRS 145 MARIMUN
• Status: Completed
• Phase: Phase 2
• First received: July 22, 2009
• Last updated: December 21, 2011
• Start date: September 2009
• Est. completion date: January 2011

Study information

• Verified date: December 2011
• Source: French National Agency for Research on AIDS and Viral Hepatitis
• 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 2011
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infection
• HIV Infections
• Infection

Intervention

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

Locations

Country	Name	City	State
France	French National Agency for Research on AIDS and Viral Hepatits	Paris

Sponsors (2)

Lead Sponsor	Collaborator
French National Agency for Research on AIDS and Viral Hepatitis	Pfizer

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of maraviroc intensification during 24 weeks in HIV infected patients with insufficient immune restoration despite controlled viral load		immunologic benefit at week 24	No
Secondary	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.		immuno-virologic evolution between week 0 and week 36	Yes