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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by Centers for Disease Control and Prevention, China.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
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
  Purpose

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 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:


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

  Eligibility

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 Sharp & Dohme Corp.
Investigators
Principal Investigator: Fujie Zhang, MD, MPH NCAIDS, China CDC
  More Information

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:
Acquired Immunodeficiency Syndrome
HIV Infections
Anti-HIV Agents
Anti-Infective Agents
Anti-Retroviral Agents
Antitussive Agents
Antiviral Agents
Central Nervous System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Respiratory System Agents
Sensory System Agents
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases
Methadone
Nevirapine
Analgesics
Analgesics, Opioid
Central Nervous System Depressants
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Narcotics
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on October 21, 2014