Optimization of Antiretroviral Therapy

Study Overview
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Brief Summary
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The combination antiretroviral therapy (cART) inhibit HIV replication effectively. However, synergy among these drugs has not been well considered. The dose of drugs used as monotherapy is the same as that used in combination therapy. Tenofovir+lamivudine+efavirenz is still the first line regimen of cART in developing countries. The side effects of these drugs are related to the concentration of drugs. 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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Optimization of Antiretroviral Therapy

Conditions
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HIV Infections

Intervention / Treatment
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* Drug: Tenofovir disoproxil fumarate
* 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: Reduced dose<br>Tenofovir 200mg +lamivudine 300mg +efavirenz 400mg PO q.d. | Drug: Tenofovir disoproxil fumarate<br>* Oral daily<br>Drug: Lamivudine<br>* Oral daily<br>Drug: Efavirenz<br>* Oral daily<br>|
| Active Comparator: Standard dose<br>Tenofovir 300mg +lamivudine 300mg +efavirenz 600mg PO q.d. | Drug: Tenofovir disoproxil fumarate<br>* Oral daily<br>Drug: Lamivudine<br>* Oral daily<br>Drug: Efavirenz<br>* Oral daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients with HIV viral road < 50 copies/ml | calculate the percentage of patients who with HIV viral road <50 copies/ml every month in two groups | 48 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cell Differentiation 4 (CD4) T cell counts |  | 48 weeks |