NCT01042652

A Trial to Compare Raltegravir Versus Nevirapine as Anchor Drug for HIV+ Chinese IDUs on Methadone Maintenance

A Pilot Study With Randomized Controlled Open-label Design to Compare Drug-drug Interaction, Antiretroviral Efficacy and Tolerability of Raltegravir Versus Nevirapine as Anchor Drug in Combination Therapy for Treatment-naive HIV+ Chinese Injection Drug Users on Methadone Maintenance

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Centers for Disease Control and Prevention, China · Other Government
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This is a pilot randomized controlled Open-label trial to compare raltegravir and nevirapine as anchor Drug in combined antiretroviral therapy(ART) for ART-naive HIV+ Chinese injection drug users who are also on methadone maintenance therapy. The investigators hypotheses include: 1. In raltegravir arm compared with nevirapine arm, fewer patients will require methadone dose adjustment to abate methadone withdrawal symptoms. Also the average methadone dose to achieve adequate serum methadone concentrations in patients on the raltegravir-based regimen will be lower compared to that of patients on the nevirapine-based regimen. 2. Clinical outcomes in terms of viral suppression, CD4 recovery and occurrence of opportunistic infections will be comparable in the two arms at 6 months and one year. 3. Patients in the raltegravir arm will have a similar or better side effect profile, retention rate, and treatment adherence compared to those in the nevirapine arm.

Conditions

• HIV
• HIV Infections

Interventions

Type	Name	Description
DRUG	Raltegravir	Raltegarvir 400mg bid

Timeline

• Start date: 2011-02-01
• Primary completion: 2012-01-01
• Completion: 2012-06-01
• First posted: 2010-01-05
• Last updated: 2011-06-15

Locations

1 site across 1 country: China