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

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01042652
• Other study ID #: X091221164
• Status: Recruiting
• Phase: N/A
• First received: January 4, 2010
• Last updated: June 14, 2011
• Start date: February 2011
• Est. completion date: June 2012

Study information

• Verified date: June 2011
• Source: Centers for Disease Control and Prevention, China
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV
• HIV Infections

Intervention

Drug:
• Raltegravir
Raltegarvir 400mg bid

Locations

Country	Name	City	State
China	Division of Treatment and Care, NCAIDS, China CDC	Beijing	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Centers for Disease Control and Prevention, China	Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The percentages of patients in both arms who require methadone dose adjustment;The average methadone dose in each arm		1 year	No
Secondary	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	No
Secondary	The occurrence of side effects, adherence and retention rates in two treatment arms.		1.5 year	Yes