NCT00966329

Switching the Non-nucleoside Reverse Transcriptase Inhibitor (NNRTI) or Protease Inhibitor (PI) to Maraviroc in HIV Subjects

Pilot Study to Assess the Safety and Efficacy of Switching the Nnrti or pi to Maraviroc in Hiv-1-infected Subjects With Persistent Viremia Suppression

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Germans Trias i Pujol Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Patients with HIV-1 infection on HAART regimen including 2 NRTI/NtRTIs plus one of the following : 1 PI/ritonavir or ATV/unboosted or 1 NNRTI, will be randomized to switch from the NNRTI/PI to maraviroc (300 mg /12 h) or to continue with the same approach.

Detailed description

This is a 48 week randomized, prospective, controlled, open-label, proof-of-concept pilot clinical trial. Patients with HIV-1 infection on HAART regimen including 2 NRTI/NtRTIs plus one of the following : 1 PI/ritonavir (lopinavir/ritonavir, atazanavir/ritonavir, fosamprenavir /ritonavir, tipranavir/ritonavir, darunavir/ritonavir) or ATV/unboosted (in a regimen without tenofovir) or 1 NNRTI (nevirapine or efavirenz). Patients will be randomized to switch from the NNRTI/PI to maraviroc (300 mg /12 h) or to continue with the same approach. The primary endpoint would be the percentage of patients who maintain virological suppression at week 48.

Conditions

• HIV
• HIV Infections

Interventions

Type	Name	Description
DRUG	maraviroc	HAART regimen including 2 NRTI/NtRTIs plus maraviroc
DRUG	control group	HAART regimen including 2 NRTI/NtRTIs plus one of the following : * 1 PI/ritonavir (lopinavir/ritonavir, atazanavir/ritonavir, fosamprenavir /ritonavir, tipranavir/ritonavir, darunavir/ritonavir) * or ATV/unboosted (in a regimen without tenofovir) * or 1 NNRTI (nevirapine or efavirenz).

Timeline

• Start date: 2009-10-01
• Primary completion: 2012-05-01
• Completion: 2012-05-01
• First posted: 2009-08-26
• Last updated: 2013-01-24

Locations

3 sites across 1 country: Spain