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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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AIDS/HIV PROBLEM

Intervention / Treatment
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* Drug: TDF+3TC+EFV


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: TDF+3TC+EFV<br> | Drug: TDF+3TC+EFV<br> <br> |

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 |