A Trial to Compare Raltegravir Versus Nevirapine as Anchor Drug for HIV+ Chinese IDUs on Methadone Maintenance
This study is currently recruiting participants.
Verified June 2011 by Centers for Disease Control and Prevention, China
Sponsor:
Centers for Disease Control and Prevention, China
Collaborator:
Merck
Information provided by:
Centers for Disease Control and Prevention, China
ClinicalTrials.gov Identifier:
NCT01042652
First received: January 4, 2010
Last updated: June 14, 2011
Last verified: June 2011
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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 | Intervention |
---|---|
HIV HIV Infections |
Drug: Raltegravir |
Study Type: | Interventional |
Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
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 |
Resource links provided by NLM:
Genetics Home Reference related topics:
complement factor I deficiency
MedlinePlus related topics:
HIV/AIDS
Drug Information available for:
Methadone
Methadone hydrochloride
Nevirapine
Raltegravir
Raltegravir potassium
U.S. FDA Resources
Further study details as provided by Centers for Disease Control and Prevention, China:
Primary Outcome Measures:
- The percentages of patients in both arms who require methadone dose adjustment;The average methadone dose in each arm [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
- The occurrence of side effects, adherence and retention rates in two treatment arms. [ Time Frame: 1.5 year ] [ Designated as safety issue: Yes ]
Estimated Enrollment: | 60 |
Study Start Date: | February 2011 |
Estimated Study Completion Date: | June 2012 |
Estimated Primary Completion Date: | January 2012 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Active Comparator: Nevirapine |
Drug: Raltegravir
Raltegarvir 400mg bid
|
Experimental: Raltegravir |
Drug: Raltegravir
Raltegarvir 400mg bid
|
![](https://webarchive.library.unt.edu/web/20130315211529im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Chinese IDUs with documented HIV-1 infection confirmed by a western blot assay.
- On stable methadone maintenance therapy at the time of enrollment.
- Antiretrovial treatment naïve and meeting clinical criteria of the Chinese national guideline to initiate antiretroviral therapy.
- Patient who is of reproductive potential agrees to use an acceptable method of birth control throughout the study. Acceptable method of birth control is defined as intrauterine device (IUD), diaphragm with spermicide, condoms, or abstinence.
Exclusion Criteria:
- Patients with allergies to or other contraindications for the selected ARV regimens.
- Patients with acute HIV infection.
- Use of concomitant therapy which can potentially interact with methadone and scheduled ARVs.
- Females who are pregnant, breast-feeding, or planning to get pregnant within the study period and using ineffective or hormonal birth control. (Note: All female patients must have a negative pregnancy test at Treatment Day 1)
- Any active and clinically significant disease or findings discovered on screening medical history, physical examination and laboratory assessment that are not resolved or stabilized within 30 days before the screening phase of this study.
- Patients with clinical or laboratory evidence of active liver disease, severe hepatic impairment /dysfunction or cirrhosis or elevated liver enzyme levels. (Note: patients co-infected with chronic hepatitis B or C will be allowed to enter the program if their condition is judged to be clinically stable.)
- Patient's education level that would interfere with the medical, adherence and withdrawal symptoms evaluation.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01042652
Locations
China, Beijing | |
Division of Treatment and Care, NCAIDS, China CDC | Recruiting |
Beijing, Beijing, China, 100050 | |
Contact: Yao Zhang, MD 8610-63132884 zhangyao1@gmail.com |
Sponsors and Collaborators
Centers for Disease Control and Prevention, China
Merck
Investigators
Principal Investigator: | Fujie Zhang, MD, MPH | NCAIDS, China CDC |
![](https://webarchive.library.unt.edu/web/20130315211529im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
No publications provided
Responsible Party: | Fujie Zhang/Director, Division of Treatment and Care, NCAIDS, China CDC |
ClinicalTrials.gov Identifier: | NCT01042652 History of Changes |
Other Study ID Numbers: | X091221164 |
Study First Received: | January 4, 2010 |
Last Updated: | June 14, 2011 |
Health Authority: | China: Ministry of Health |
Keywords provided by Centers for Disease Control and Prevention, China:
Methadone HIV Raltegravir Antiretroviral |
Intravenous Drug User Methadone Maintenance Treatment Naive |
Additional relevant MeSH terms:
HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Methadone Nevirapine Analgesics, Opioid Analgesics |
Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Central Nervous System Depressants Antitussive Agents Respiratory System Agents Narcotics Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Reverse Transcriptase Inhibitors |
ClinicalTrials.gov processed this record on March 14, 2013