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

Efficacy and Safety of Tenofovir Disoproxil Fumarate Plus Lamivudine Plus Efavirenz Regimen as First-line Antiretroviral Therapy for ART-naive Chinese Patients With HIV-1 Infection

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.

Study Overview

• Status: Unknown
• Conditions: AIDS/HIV PROBLEM
• Intervention / Treatment: Drug: TDF+3TC+EFV

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 Type: Interventional
• Enrollment (Anticipated): 500
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100730
      • Peking Union Medical College Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: TDF+3TC+EFV	Drug: TDF+3TC+EFV

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 48	48 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Peking Union Medical College

Publications and helpful links

General Publications

• Fan H, Guo F, Hsieh E, Chen WT, Lv W, Han Y, Xie J, Li Y, Song X, Li T. Incidence of hypertension among persons living with HIV in China: a multicenter cohort study. BMC Public Health. 2020 Jun 1;20(1):834. doi: 10.1186/s12889-020-08586-9.
• Luo L, Wang N, Yue Y, Han Y, Lv W, Liu Z, Qiu Z, Lu H, Tang X, Zhang T, Zhao M, He Y, Shenghua H, Wang M, Li Y, Huang S, Li Y, Liu J, Tuofu Z, Routy JP, Li T. The effects of antiretroviral therapy initiation time on HIV reservoir size in Chinese chronically HIV infected patients: a prospective, multi-site cohort study. BMC Infect Dis. 2019 Mar 14;19(1):257. doi: 10.1186/s12879-019-3847-0.

Study record dates

Study Major Dates

• Study Start: May 1, 2013
• Primary Completion (Anticipated): October 1, 2015
• Study Completion (Anticipated): December 1, 2015

Study Registration Dates

• First Submitted: August 24, 2012
• First Submitted That Met QC Criteria: April 26, 2013
• First Posted (Estimate): May 1, 2013

Study Record Updates

• Last Update Posted (Estimate): May 1, 2013
• Last Update Submitted That Met QC Criteria: April 26, 2013
• Last Verified: April 1, 2013

More Information

Terms related to this study

• Other Study ID Numbers: CACT1215