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

Phase 2

Completed

• Conditions: HIV
• Interventions: Drug: generic FDC of TDF/3TC/EFV

• Registration Number: NCT01160120
• Lead Sponsor: The HIV Netherlands Australia Thailand Research Collaboration

Brief 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.

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TDF/3TC/EFV demonstrated bioequivalent to original individual EFV 3TC and TDF in Indian healthy volunteers (unpublished data).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

• Study Start: 2010-06
• Study First Submitted: 2010-06-09
• Study First Submitted QC: 2010-07-09
• Study First Posted: 2010-07-12
• Primary Completion: 2013-05
• Study Completion: 2015-06
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-15
• Last Update Posted: 2020-07-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	generic FDC of TDF/3TC/EFV	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.

Primary Outcome Measures

Name	Time	Method
mid levels of TDF, 3TC, and EFV between brand and generic	144 weeks	mid levels of TDF, 3TC, and EFV between brand and generic

Secondary Outcome Measures

Name	Time	Method
kidney, liver, CD4 and viral load overtime	144 weeks	kidney, liver, CD4 and viral load overtime

Trial Locations

Locations (1)

HIV-NAT; 🇹🇭 Bangkok, Thailand