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

NCT01042652 | Unknown

• 1 other identifier: X091221164
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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. 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. 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. 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.

Conditions

HIV; HIV Infections

Keywords

Methadone; HIV; Raltegravir; Antiretroviral; Intravenous Drug User; Methadone Maintenance; Treatment Naive

Outcome Measures

Primary Outcomes (1)

• The percentages of patients in both arms who require methadone dose adjustment；The average methadone dose in each arm

  1 year

Secondary Outcomes (2)

• Changes in CD4+ T lymphocyte count and viral load at weeks 24 and 48 from baseline, and the documented opportunistic infections during study period.

  1.5 year

• The occurrence of side effects, adherence and retention rates in two treatment arms.

  1.5 year

Study Arms (2)

Nevirapine

ACTIVE COMPARATOR

Drug: Raltegravir

Raltegravir

EXPERIMENTAL

Drug: Raltegravir

Interventions

Raltegravir DRUG

Raltegarvir 400mg bid

Nevirapine; Raltegravir

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centers for Disease Control and Prevention, China: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

Division of Treatment and Care, NCAIDS, China CDC

Beijing, Beijing Municipality, 100050, China

RECRUITING

MeSH Terms

Conditions

HIV Infections

Interventions

Raltegravir Potassium

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pyrrolidinones; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Fujie Zhang, MD, MPH

  NCAIDS, China CDC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: January 4, 2010
• First Posted: January 5, 2010
• Study Start: February 1, 2011
• Primary Completion: January 1, 2012
• Study Completion: June 1, 2012
• Last Updated: June 15, 2011

Record last verified: 2011-06

Locations

CN (1)