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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01160120
Recruitment Status : Completed
First Posted : July 12, 2010
Last Update Posted : February 22, 2016
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
HIV Drug: generic FDC of TDF/3TC/EFV Phase 2

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TDF/3TC/EFV demonstrated bioequivalent to original individual EFV 3TC and TDF in Indian healthy volunteers (unpublished data).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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Generic Fixed Dose Combination (FDC) of Tenofovir(TDF) /Lamivudine(3TC)/Efavirenz (EFV) Tablets 300/300/600 mg
Study Start Date : June 2010
Primary Completion Date : May 2013
Study Completion Date : June 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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.

Outcome Measures

Primary Outcome Measures :
  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 Outcome Measures :
  1. kidney, liver, CD4 and viral load overtime [ Time Frame: 144 weeks ]
    kidney, liver, CD4 and viral load overtime

Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01160120

Bangkok, Thailand, 10330
Sponsors and Collaborators
The HIV Netherlands Australia Thailand Research Collaboration
Mylan Laboratories
Principal Investigator: Anchalee Avihingsanon, MD, PhD The HIV Netherlands Australia Thailand Research Collaboration
More Information

Additional Information:
Avihingsanon A, Sophonphan J, Thammajaruk N, Chaihong P, Burger D, Cressey TR, Ramautarsing RA, Praditornsilpa K, Avihingsanon Y, Ruxrungtham K and HIV-NAT 114 study team. Plasma Tenofovir Concentrations and Proximal Tubular Dysfunction in HIV-Infected Adults Receiving Tenofovir in Thailand. AIDS Clin Res 2015, 6:7 Doi: http://dx.doi.org/10.4172/2155-6113.1000477

Responsible Party: The HIV Netherlands Australia Thailand Research Collaboration
ClinicalTrials.gov Identifier: NCT01160120     History of Changes
Other Study ID Numbers: HIV-NAT 118
First Posted: July 12, 2010    Key Record Dates
Last Update Posted: February 22, 2016
Last Verified: February 2016

Keywords provided by The HIV Netherlands Australia Thailand Research Collaboration:
fixed dose combinations
therapeutic drug levels
safety and efficacy
To evaluation new formulations of FDC of TDF/3TC/EFV

Additional relevant MeSH terms:
Antiviral Agents
Anti-Infective Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Anti-HIV Agents
Cytochrome P-450 CYP2C9 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Cytochrome P-450 CYP2C19 Inhibitors
Cytochrome P-450 CYP2B6 Inducers
Cytochrome P-450 Enzyme Inducers
Cytochrome P-450 CYP3A Inducers