ART Drug Dosage Adjustment in HIV-infected Population

Study Overview
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Brief Summary
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The purpose of this study is to determine efficacy of the combination of low dose of Tenofovir, Efavirenz and Lamivudine in treating HIV-infection.

Detailed Description
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The feedback system control (FSC) technique has been developed to rapidly identify optimal combinations for therapeutic purposes. Low dose of TDF+3TC+EFV combination has been test in vitro study by FSC which showed high efficacy and now the investigators apply it to human to further optimize the ART combination.

Official Title
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ART Drug Dosage Adjustment Using FSCII in Chinese HIV-infected Population

Conditions
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HIV Infections

Intervention / Treatment
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* Drug: Tenofovir(TDF)+Lamivudine(3TC)+Efavirenz(EFV)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: HIV antibody positive HIV RNA below 10*E5 copies/ml CD4 T cell count above 200 cells/ml Provision of written informed consent Exclusion Criteria: HIV genotyping resistant to investigating drug Pregnant, breastfeeding, or lactating Any serious or active medical or psychiatric illness which, in the opinion of the Investigator, would interfere with treatment, assessment, compliance with the protocol, or subject safety. This would include any active clinically significant renal, cardiac, pulmonary, vascular, or metabolic (thyroid disorders, adrenal disease) illness, or malignancy Medical or psychiatric condition or occupational responsibilities that may preclude compliance with the protocol Laboratory blood values: Haemoglobin <7.0 grams/decilitre (g/dL) Neutrophil count <500/mm3 Platelet count <50,000/mm3 Aspartate aminotransferase or Alanine transaminase >5 times Upper Limit of Normal (ULN) Subjects with an estimated creatinine clearance of <50 mL/minute

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 |
| --- | --- |
| Experimental: Low-dose<br>Tenofovir(TDF)+Lamivudine(3TC)+Efavirenz(EFV) | Drug: Tenofovir(TDF)+Lamivudine(3TC)+Efavirenz(EFV)<br>* The first 2 weeks, TDF (300 mg) + 3-TC (300 mg) + EFV (400 mg); week 3, TDF (200 mg) + 3-TC (300 mg) + EFV (400 mg ); week 4, TDF (150 mg) + 3-TC (300 mg) + EFV (400 mg).From week5, if the HIV viral load decreased as expected or no rebound, use TDF (200 mg) + 3-TC (300 mg) + EFV (400 mg) until study complete; if the viral load increases, switch to the standard treatment regimen: TDF (300 mg) + 3-TC (300 mg) + EFV (600 mg).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HIV viral load |  | 48 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CD4 Count |  | 48 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV Infections, Tenofovir, Efavirenz