Efficacy and Safety of TDF+3TC+EFV in Adults With HIV/HBV Coinfection

• Status: Completed
• Trial end date: 2013-06-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a Phase 4 single-arm, post-marketing clinical trial evaluating the efficacy and safety of tenofovir disoproxil fumarate, lamivudine and efavirenz in adults with human immunodeficiency virus-1 and hepatitis B virus coinfection.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Center for AIDS/STD Control and Prevention, China CDC
• Collaborator: Gilead Sciences

Criteria

Inclusion Criteria:

• Serologically-confirmed HIV and HBV infection

• Willingness to participate in a clinical trial

• No previous or current use of antiretroviral regimen

• Clinical conditions stable

• Blood creatinine less than 3 times the upper limit of normal values. HBV DNA>1000copies/ml, Tbil<34umol/L,ALT<400U/L

• With clinical indications for HAART

Exclusion Criteria:

• Patient refuses to sign the consent to participate

• Unwillingness to adhere to visit schedule or maintain adherence with medications

• Illnesses so serve as to likely require hospitalization

• With other conditions that not suitable to be enrolled will be subject to medical review