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Completed

NCT Number: NCT01160120

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.

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Key information

Conditions

HIV

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

HIV-NAT

Bangkok, 10330, Thailand

About this study

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TDF/3TC/EFV demonstrated bioequivalent to original individual EFV 3TC and TDF in Indian healthy volunteers (unpublished data).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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

generic FDC of TDF/3TC/EFV

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.

Primary outcomes

  1. mid levels of TDF, 3TC, and EFV between brand and generic

    Time frame: 144 weeks

    mid levels of TDF, 3TC, and EFV between brand and generic

Secondary outcomes

  1. kidney, liver, CD4 and viral load overtime

    Time frame: 144 weeks

    kidney, liver, CD4 and viral load overtime

Sponsors and collaborators

Lead sponsor

The HIV Netherlands Australia Thailand Research Collaboration

Other

Collaborators

  • Mylan Laboratories

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2013
Study completion
2015
First posted
Jul 12, 2010
Registry last updated
Jul 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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