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

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.