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. 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
Merck Sharp & Dohme Corp.
Information provided by:
Centers for Disease Control and Prevention, China

Brief 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.

Condition or disease Intervention/treatment Phase
HIV HIV Infections Drug: Raltegravir Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : February 2011
Estimated Primary Completion Date : January 2012
Estimated Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Active Comparator: Nevirapine Drug: Raltegravir
Raltegarvir 400mg bid

Experimental: Raltegravir Drug: Raltegravir
Raltegarvir 400mg bid

Primary Outcome Measures :
  1. The percentages of patients in both arms who require methadone dose adjustment;The average methadone dose in each arm [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. 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 ]
  2. The occurrence of side effects, adherence and retention rates in two treatment arms. [ Time Frame: 1.5 year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

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 identifier (NCT number): NCT01042652

China, Beijing
Division of Treatment and Care, NCAIDS, China CDC Recruiting
Beijing, Beijing, China, 100050
Contact: Yao Zhang, MD    8610-63132884   
Sponsors and Collaborators
Centers for Disease Control and Prevention, China
Merck Sharp & Dohme Corp.
Principal Investigator: Fujie Zhang, MD, MPH NCAIDS, China CDC

Responsible Party: Fujie Zhang/Director, Division of Treatment and Care, NCAIDS, China CDC Identifier: NCT01042652     History of Changes
Other Study ID Numbers: X091221164
First Posted: January 5, 2010    Key Record Dates
Last Update Posted: June 15, 2011
Last Verified: June 2011

Keywords provided by Centers for Disease Control and Prevention, China:
Intravenous Drug User
Methadone Maintenance
Treatment Naive

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Raltegravir Potassium
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
HIV Integrase Inhibitors
Integrase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Antitussive Agents
Respiratory System Agents
Reverse Transcriptase Inhibitors