A Trial to Compare Raltegravir Versus Nevirapine as Anchor Drug for HIV+ Chinese IDUs on Methadone Maintenance
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01042652|
Recruitment Status : Unknown
Verified June 2011 by Centers for Disease Control and Prevention, China.
Recruitment status was: Recruiting
First Posted : January 5, 2010
Last Update Posted : June 15, 2011
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:
- 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.
- 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.
- 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.
|Condition or disease||Intervention/treatment||Phase|
|HIV HIV Infections||Drug: Raltegravir||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||February 2011|
|Estimated Primary Completion Date :||January 2012|
|Estimated Study Completion Date :||June 2012|
|Active Comparator: Nevirapine||
Raltegarvir 400mg bid
Raltegarvir 400mg bid
- The percentages of patients in both arms who require methadone dose adjustment；The average methadone dose in each arm [ Time Frame: 1 year ]
- Changes in CD4+ T lymphocyte count and viral load at weeks 24 and 48 from baseline, and the documented opportunistic infections during study period. [ Time Frame: 1.5 year ]
- The occurrence of side effects, adherence and retention rates in two treatment arms. [ Time Frame: 1.5 year ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01042652
|Division of Treatment and Care, NCAIDS, China CDC||Recruiting|
|Beijing, Beijing, China, 100050|
|Contact: Yao Zhang, MD 8610-63132884 firstname.lastname@example.org|
|Principal Investigator:||Fujie Zhang, MD, MPH||NCAIDS, China CDC|