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

Peking Union Medical College

Status

Unknown

Conditions

AIDS/HIV PROBLEM

Treatments

Drug: TDF+3TC+EFV

Study type

Interventional

Funder types

Other

Identifiers

NCT01844297

CACT1215

Details and patient eligibility

About

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.

Full description

This study is a prospective, open-label, multi-centered clinical trial to assess the virologic suppression and immune recovery rates as well as tolerability of the regimen 3TC+TDF+EFV in ARV-naive Chinese population.

500 eligible participants will be recruited to take the regimen If the patient fails to tolerate EFV, it can be substituted by NVP when CD4 < 250/μL, and by LPV/r when CD4 > 250/uL. If the patient fails to tolerate TDF, AZT will be an alternative, except when Hb < 90/L or neutrophil count < 0.75×109/L. The participants will be followed up by months 0.5, 1, 2 ,3 and every 3 months subsequently for 2 years.

The efficacy of the regimen will be evaluated by comparison between different points along the time line and previous regimens. The safety of the regimen will be assessed by monitoring kidney function, bone density, cardiovascular profile, lipid profile, liver function etc as well as other adverse events.

Enrollment

500 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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