Efavirenz 400mg in Treatment-naïve Chinese HIV-infected Patients

Study Overview
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Brief Summary
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Evaluating the efficacy, pharmacodynamics, and safety of Efavirenz 400mg in treatment-naïve Chinese HIV-infected patients.

Detailed Description
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Treatment-naive HIV-infected patients are designed to enroll and receive efavirenz 400mg combined with tenofovir (TDF) and lamivudine (3TC) as initial antiretroviral regimens, and monitoring for 48 weeks, to evaluate efavirenz concentration, T-cell subsets, HIV RNA load, and neuropsychiatric tests with Hamilton depression scale (HAMD) and Pittsburgh sleep quality index (PSQI) at baseline, 4, 12, 24, 48 weeks.

Official Title
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Pharmacodynamics of Efavirenz 400mg in Treatment-naïve Chinese HIV-infected Patients in a Prospective Cohort Study

Conditions
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HIV-1-infection

Intervention / Treatment
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* Drug: Efavirenz 400mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: (1) HIV treatment-naïve, (2) age between 18 years or older, (3) be willing to complete the HAMD and PSQI scale and follow-up regularly, (5) not participating in other studies. Exclusion Criteria: (1) acute HIV-1-infected patients, (2) an AIDS-defining illness such as pneumocystis pneumonia, tuberculosis within 2 weeks of entry, (3) transaminase and alkaline phosphatase levels beyond three times the upper limit of the normal range, bilirubin level more than 2.5 times the upper limit of the normal range, and serum creatinine level excess 1.5 times the upper limit of the normal range, (4) pregnancy or breast feeding

Ages Eligible for Study
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Minimum Age: 18 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 |
| --- | --- |
| Experimental: Efavirenz 400mg+TDF+3TC<br>Combined antiretroviral therapy(cART) consisting of three regimens such as efavirenz, tenofovir and lamivudine is an effective measure for the treatment of HIV-1 infection.Efavirenz 600mg daily was approved by the US Food and Drug Administration in 1998. In this single-arm research, patients were treated with a reduced 400mg dose of efavirenz combined with tenofovir 300mg and lamivudine 300mg once a day. This treatment had to be maintained indefinitely due to the existence of HIV reservoir. | Drug: Efavirenz 400mg<br>* HIV-infected patients were treated with efavirenz 400mg combined with tenofovir 300mg and lamivudine 300mg.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Viral suppression | The proportion of patients with viral load less than 50 copies/mL | 48 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Drug concentration | The proportion of patients with plasma efavirenz concentration between 1 mg/L and 4mg/L | 48 weeks | 
| Neuropsychiatric adverse events | The proportion of patients with HAMD <8 and PSQI <10 (less neuropsychiatric adverse effects) | 48 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Efavirenz 400mg, Chinese HIV-infected patients