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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 : July 17, 2020
Sponsor:
Collaborator:
Mylan Laboratories
Information provided by (Responsible Party):
The HIV Netherlands Australia Thailand Research Collaboration

Tracking Information
First Submitted Date  ICMJE June 9, 2010
First Posted Date  ICMJE July 12, 2010
Last Update Posted Date July 17, 2020
Study Start Date  ICMJE June 2010
Actual Primary Completion Date May 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 25, 2015)
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
Original Primary Outcome Measures  ICMJE
 (submitted: July 9, 2010)
mid levels of TDF, 3TC, and EFV between brand and generic [ Time Frame: 48 weeks ]
mid levels of TDF, 3TC, and EFV between brand and generic
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 25, 2015)
kidney, liver, CD4 and viral load overtime [ Time Frame: 144 weeks ]
kidney, liver, CD4 and viral load overtime
Original Secondary Outcome Measures  ICMJE
 (submitted: July 9, 2010)
kidney, liver, CD4 and viral load overtime [ Time Frame: 48 weeks ]
kidney, liver, CD4 and viral load overtime
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Therapeutic Drug Monitoring (TDM) in Generic Tenofovir/Lamivudine/Efavirenz
Official Title  ICMJE Generic Fixed Dose Combination (FDC) of Tenofovir(TDF) /Lamivudine(3TC)/Efavirenz (EFV) Tablets 300/300/600 mg
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE HIV
Intervention  ICMJE 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.
Study Arms  ICMJE 1
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.
Intervention: Drug: generic FDC of TDF/3TC/EFV
Publications * 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 9, 2010)
100
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2015
Actual Primary Completion Date May 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Thailand
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01160120
Other Study ID Numbers  ICMJE HIV-NAT 118
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party The HIV Netherlands Australia Thailand Research Collaboration
Study Sponsor  ICMJE The HIV Netherlands Australia Thailand Research Collaboration
Collaborators  ICMJE Mylan Laboratories
Investigators  ICMJE
Principal Investigator: Anchalee Avihingsanon, MD, PhD The HIV Netherlands Australia Thailand Research Collaboration
PRS Account The HIV Netherlands Australia Thailand Research Collaboration
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP