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

HIV Infections Clinical Trial

Official title:
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

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01042652
Study type Interventional
Source Centers for Disease Control and Prevention, China
Contact
Status Recruiting
Phase N/A
Start date February 2011
Completion date June 2012
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