Efficacy and Safety of Tenofovir Plus Lamivudine Plus Efavirenz Regimen as First-line Antiretroviral Therapy

• Status: Unknown status
• Trial end date: 2015-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This study aims to evaluate the safety and effectiveness of the tenofovir disoproxil fumarate (TDF) + lamivudine (3TC) + efavirenz (EFV) regimen in antiretroviral therapy (ART)-naive Chinese HIV/AIDS patients.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Peking Union Medical College
• Treatments: Efavirenz; Lamivudine; Tenofovir

Criteria

Inclusion Criteria:

• age between 18-65 years of either gender

• HIV-1 antibody seropositive detected by ELISA and confirmed by western blot

• CD4 cell count < 500/ul

• Signed informed consent, with no condition that precludes follow-up for 2 years

• No plan to move out of the area during the trial

• antiretroviral therapy naive

Exclusion Criteria:

• patients in acute phase of HIV infection

• patients with ongoing opportunistic infection or AIDS-related malignancies; or with opportunistic infection within previous 3 months and still unstable within 14 days before inclusion

• patients with the any of the following test results during screening for inclusion:

• WBC count < 2000/ul,

• neutrophil count < 1000/ul,

• Hb < 9g/dl,

• platelet count < 75000/ul,

• serum creatinine > 1.5 ULN,

• transaminases or alkaline phosphatase > 3 ULN,

• total bilirubin > 2 ULN,

• serum creatinine kinase > 2 ULN

• CCr < 60ml/min

• Pregnancy and breastfeeding

• Intravenous drug user

• Severe neuropathy or mental disorder

• history of alcohol abuse and unable to withdrawal

• Severe peptic ulcer disease

• Non-Chinese nationality