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A Pilot Randomized Open-label Trial to Compare Raltegravir Versus Nevirapine as Anchor Drug for HIV+ Chinese IDUs on Methadone Maintenance

2014-08-27 03:16:53 | BioPortfolio

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.

Study Design

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

Conditions

HIV

Intervention

Raltegravir

Location

Division of Treatment and Care, NCAIDS, China CDC
Beijing
Beijing
China
100050

Status

Not yet recruiting

Source

Centers for Disease Control and Prevention, China

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:16:53-0400

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PubMed Articles [22 Associated PubMed Articles listed on BioPortfolio]

Raltegravir 1200 mg once daily vs 400 mg twice daily, with emtricitabine and tenofovir disoproxil fumarate, for previously untreated HIV-1 infection: Week 96 results from ONCEMRK, a randomized, double-blind, non-inferiority trial.

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Similar long-term efficacy of dual therapy containing raltegravir and a boosted protease inhibitor versus standard triple therapies in pretreated HIV-1-infected patients in a retrospective, real-life cohort of 14 years.

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Raltegravir plus abacavir/lamivudine in virologically suppressed HIV-1-infected patients: 48-week results of the KIRAL study.

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Dolutegravir (DTG)-containing regimens after receiving raltegravir (RAL) or elvitegravir (EVG): Durability and virological response in a large Italian HIV drug resistance network (ARCA).

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Use of Triple Combination Antiretroviral Therapy With Raltegravir as Empiric HIV Therapy in the High-Risk HIV-Exposed Newborn.

The recent approval of raltegravir granules for suspension in the newborn population offers a new option for the antiretroviral prophylaxis of newborns for the prevention of perinatal transmission. Ho...

Medical and Biotech [MESH] Definitions

A pyrrolidinone derivative and HIV INTEGRASE INHIBITOR that is used in combination with other ANTI-HIV AGENTS for the treatment of HIV INFECTION.

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