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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-06-30

Study Completion Date

2015-06-30

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.

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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TDF/3TC/EFV demonstrated bioequivalent to original individual EFV 3TC and TDF in Indian healthy volunteers (unpublished data).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.

Conditions

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HIV

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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1

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.

Group Type OTHER

generic FDC of TDF/3TC/EFV

Intervention Type DRUG

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.

Interventions

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generic FDC of TDF/3TC/EFV

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.

Intervention Type DRUG

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No