AIDS
Conditions
Interventions
RPV group:taking Rilpivirine RPV+TDF+3TC and methadone
EFV:taking Rilpivirine RPV+TDF+3TC and methadone
Sponsors
Yunnan Provincial Infectious Disease Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Male or female subjects, aged 18 years or older; 2.IDU who is on Methadone maintain therapy at the time of enrollment, who is at Methadone maintenance period at 2 to 3 months or longer with a fixed Methadone dosage, and already experienced initiation period and adjustment period; 3. HIV-1 treatment-naive patients and meet the clinical criteria of the Chinese national guidelines to initiate ART; CD4 less than 500/mm3; VL less than 100k copies/ml; 4. Patient who is evaluated can be adherent to HIV ART; 5. 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
Exclusion criteria: 1. Male or female subjects, aged 18 years or older; 2. IDU who is on Methadone maintain therapy at the time of enrollment, who is at Methadone maintenance period at 2 to 3 months or longer with a fixed Methadone dosage, and already experienced initiation period and adjustment period; 3. HIV-1 treatment-naive patients and meet the clinical criteria of the Chinese national guidelines to initiate ART; CD4 less than 500/mm3; VL less than 100k copies/ml; 4. Patient who is evaluated can be adherent to HIV ART; 5. 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; 6. Patients with allergies to or other contraindications for the selected ARV regimens; 7. Patients with acute HIV infection; 8. Use of concomitant therapy which can potentially interact with Methadone and scheduled ARVs; 9. Females who are pregnant, breast-feeding, or planning to get pregnant within the study period and using ineffective or hormonal birth control; 10. 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; 11. Patients with clinical or laboratory evidence of active liver disease, severe hepatic impairment /dysfunction or cirrhosis or elevated liver enzyme levels. (Note: patients co-infection with chronic hepatitis B or C will be allowed to enter the program if their liver function show 1 to 2 level abnormity, ALT lower than 200U/L or TBIL lower than 2.5m/dl, but clinical stabilized and liver is symptomatic treated); 12. Patient's education level that would interfere with the medical, adherence and withdrawal symptoms evaluation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HIV-RNA;CD4 cell amounts;Safety indexes;Pharmacokinetics indexes;the withdrawal symptoms;Methadone dosage adjustmen; | — |
Countries
China
Contacts
Public ContactLi Huiqing
Outcome results
None listed