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

2014-08-27 03:12:18 | BioPortfolio

Summary

The purpose of this study is to determine the mid levels of the tenofovir, lamivudine, and efavirenz, and 48 weeks safety and efficacy of the generic fixed dose combination of tenofovir /lamivudine/efavirenz tablets 300/300/600 mg in Thai HIV-infected patients.

Description

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TDF/3TC/EFV demonstrated bioequivalent to original individual EFV 3TC and TDF in Indian healthy volunteers (unpublished data).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

Study Design

Control: Active Control, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label

Conditions

HIV

Intervention

generic FDC of TDF/3TC/EFV

Location

Hiv-Nat
Bangkok
Thailand
10330

Status

Recruiting

Source

The HIV Netherlands Australia Thailand Research Collaboration

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:12:18-0400

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