Dosing of Tenofovir and Efavirenz in Antiretroviral Therapy

Study Overview
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Brief Summary
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Tenofovir+lamivudine+efavirenz is still the first line regimen of combination antiretroviral therapy in developing countries. Based on our previous data, we aim to evaluate whether reduce the dose of tenofovir and efavirenz could decreasing the incidence of the side effects while not scarifying their virological efficacy.

Official Title
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The Optimization of HAART for Chinese--a RCT Study

Conditions
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HIV Infections

Intervention / Treatment
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* Drug: Tenofovir
* Drug: Lamivudine
* Drug: Efavirenz


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: HIV antibody positive Chinese nationality Naïve to antiretroviral therapy Willing to start antiretroviral therapy Provision of written informed consent Exclusion Criteria: Pregnant, breastfeeding, or lactating Females try to get pregnant during the research period Subjects who allergic to any of the research drugs Subjects that taking other drugs that known to impact the absorption, distribution, metabolism and excretion of the research drugs 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 <9.0 grams/decilitre (g/dL) Neutrophil count <1500/mm3 Platelet count <75,000/mm3 Aspartate aminotransferase or Alanine transaminase >3 times Upper Limit of Normal (ULN) Total bilirubin >3 times Upper Limit of Normal (ULN) Subjects with an estimated creatinine clearance of <90 mL/minute

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br>Tenofovir 200mg + Lamivudine 300mg +Efavirenz 400mg PO Quaque die | Drug: Tenofovir<br>* Tenofovir Disoproxil Fumarate<br>Drug: Lamivudine<br>* Lamivudine<br>Drug: Efavirenz<br>* Efavirenz<br>|
| Active Comparator: Arm 2<br>Tenofovir 300mg + Lamivudine 300mg +Efavirenz 600mg PO Quaque die | Drug: Tenofovir<br>* Tenofovir Disoproxil Fumarate<br>Drug: Lamivudine<br>* Lamivudine<br>Drug: Efavirenz<br>* Efavirenz<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients with HIV RNA<50 Copies/ml |  | 48 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events |  | 48 weeks |