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

HIV Clinical Trial

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

Clinical Trial Summary

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.

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TDF/3TC/EFV demonstrated bioequivalent to original individual EFV 3TC and TDF in Indian healthy volunteers (unpublished data).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

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01160120
Study type Interventional
Source The HIV Netherlands Australia Thailand Research Collaboration
Contact
Status Completed
Phase Phase 2
Start date June 2010
Completion date June 2015
View Details
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