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

Not Applicable

• Conditions: AIDS/HIV PROBLEM
• Interventions: Drug: TDF+3TC+EFV

• Registration Number: NCT01844297
• Lead Sponsor: Peking Union Medical College

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2012-08-24
• Status Verified: 2013-04
• Study First Submitted QC: 2013-04-26
• Last Update Submitted: 2013-04-26
• Study Start: 2013-05
• Study First Posted: 2013-05-01
• Last Update Posted: 2013-05-01
• Primary Completion: 2015-10
• Study Completion: 2015-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 500

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
TDF+3TC+EFV	TDF+3TC+EFV	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 96	96 weeks
Percentage of Participants With HIV-1 RNA < 40 Copies/mL at Week 96	96 weeks
Change From Baseline in CD4 count at Week 48	Baseline and 48 weeks
Change From Baseline in CD4 count at Week 96	Baseline and 96 weeks
Incidence of adverse events and laboratory abnormalities from baseline to week 48	48 weeks
Incidence of adverse events and laboratory abnormalities from baseline to week 96	96 weeks

Trial Locations

Locations (1)

Peking Union Medical College Hospital; 🇨🇳 Beijing, Beijing, China