Therapeutic Drug Monitoring (TDM) in Generic Tenofovir/Lamivudine/Efavirenz
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.
|Study Design:||Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
|Official Title:||Generic Fixed Dose Combination (FDC) of Tenofovir(TDF) /Lamivudine(3TC)/Efavirenz (EFV) Tablets 300/300/600 mg|
- mid levels of TDF, 3TC, and EFV between brand and generic [ Time Frame: 144 weeks ] [ Designated as safety issue: Yes ]mid levels of TDF, 3TC, and EFV between brand and generic
- kidney, liver, CD4 and viral load overtime [ Time Frame: 144 weeks ] [ Designated as safety issue: Yes ]kidney, liver, CD4 and viral load overtime
|Study Start Date:||June 2010|
|Estimated Study Completion Date:||May 2015|
|Primary Completion Date:||May 2013 (Final data collection date for primary outcome measure)|
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
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.
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TDF/3TC/EFV demonstrated bioequivalent to original individual EFV 3TC and TDF in Indian healthy volunteers (unpublished data).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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01160120
|Bangkok, Thailand, 10330|
|Principal Investigator:||Anchalee Avihingsanon, MD, PhD||The HIV Netherlands Australia Thailand Research Collaboration|