Therapeutic Drug Monitoring (TDM) in Generic Tenofovir/Lamivudine/Efavirenz

Study Overview
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Brief Summary
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The purpose of this study is to determine the mid levels of the tenofovir, lamivudine, and efavirenz, and 144 weeks safety and efficacy of the generic fixed dose combination of tenofovir /lamivudine/efavirenz tablets 300/300/600 mg in Thai HIV-infected patients.

Detailed Description
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The trial drug FDC of TDF/3TC/EFV is a new formulation combining fixed doses of the nucleoside reverse transcriptase inhibitors lamivudine 300 mg and tenofovir disoproxil fumarate 300 mg with the non nucleoside reverse transcriptase inhibitor efavirenz 600 mg for once daily and one-tablet HAART. Co-formulated TDF/3TC/EFV demonstrated bioequivalent to original individual EFV 3TC and TDF in Indian healthy volunteers (unpublished data). It has not been evaluated in clinical trials.

Official Title
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Generic Fixed Dose Combination (FDC) of Tenofovir(TDF) /Lamivudine(3TC)/Efavirenz (EFV) Tablets 300/300/600 mg

Conditions
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HIV

Intervention / Treatment
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* Drug: generic FDC of TDF/3TC/EFV


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Signed informed consent Evidence of HIV infection Age> 18 years On a TDF/3TC/EFV (separated pills) containing HAART regimen with a VL < 50 copies within 24 weeks or ARV naïve eGFR >70 cc/min Currently having no AIDS defining illness No history of NRTI/NNRTI/PI failure Willing to adhere to the protocol requirements Exclusion Criteria: Any history of taking CYP450 inhibitors or inducers drugs within 14 days of enrollment in the study Current pregnancy or lactating or plan to be pregnant Active opportunistic infection ALT more than 2 x upper limit Creatinine more than 1.5 time the upper limit Active drug abuse

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: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 1<br>Patients can be either treatment-naïve or treatment-experienced when entering this clinical trial. After meeting the inclusion and exclusion criteria, patients will start with generic FDC of TDF/3TC/EFV 1 pill a day at night time. Only patient who are on individual TDF 3TC and EFV will undergo TDM sampling ( 11-13 hours after dosing) at baseline. | Drug: generic FDC of TDF/3TC/EFV<br>* Patients who were on individual TDF 3TC and EFV regimen before baseline will undergo TDM at baseline. Therapeutic drug monitoring (TDM) of generic FDC of TDF/3TC/EFV will be done after 4 weeks, to ensure steady state. At baseline and week 4 safety data will be obtained. In order to assess the efficacy and the long term safety of this drug, at week 12, 24 and 48 viral load, CD4 and safety parameters will be obtained.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mid levels of TDF, 3TC, and EFV between brand and generic | mid levels of TDF, 3TC, and EFV between brand and generic | 144 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| kidney, liver, CD4 and viral load overtime | kidney, liver, CD4 and viral load overtime | 144 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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fixed dose combinations, tenofovir, lamivudine, efavirenz, therapeutic drug levels, safety and efficacy, HIV, To evaluation new formulations of FDC of TDF/3TC/EFV