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

Peking Union Medical College500 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

500

Conditions

AIDS/HIV PROBLEM

Interventions

TDF+3TC+EFVDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Outcomes

Primary Outcomes

Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 48

Time frame: 48 weeks

Secondary Outcomes

Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 96

Time frame: 96 weeks

Percentage of Participants With HIV-1 RNA < 40 Copies/mL at Week 96

Time frame: 96 weeks

Change From Baseline in CD4 count at Week 48

Time frame: Baseline and 48 weeks

Change From Baseline in CD4 count at Week 96

Time frame: Baseline and 96 weeks

Incidence of adverse events and laboratory abnormalities from baseline to week 48

Time frame: 48 weeks

Incidence of adverse events and laboratory abnormalities from baseline to week 96

Time frame: 96 weeks

Central Contacts

Tai sheng Li, MD

CONTACT

86-10-69155086 litsh@263.net

Data from ClinicalTrials.gov

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