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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Matrix Laboratories Ltd
Information provided by (Responsible Party):
The HIV Netherlands Australia Thailand Research Collaboration
ClinicalTrials.gov Identifier:
NCT01160120
First received: June 9, 2010
Last updated: March 25, 2015
Last verified: March 2015

June 9, 2010
March 25, 2015
June 2010
May 2013   (final data collection date for primary outcome measure)
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
mid levels of TDF, 3TC, and EFV between brand and generic [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
mid levels of TDF, 3TC, and EFV between brand and generic
Complete list of historical versions of study NCT01160120 on ClinicalTrials.gov Archive Site
kidney, liver, CD4 and viral load overtime [ Time Frame: 144 weeks ] [ Designated as safety issue: Yes ]
kidney, liver, CD4 and viral load overtime
kidney, liver, CD4 and viral load overtime [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
kidney, liver, CD4 and viral load overtime
Not Provided
Not Provided
 
Therapeutic Drug Monitoring (TDM) in Generic Tenofovir/Lamivudine/Efavirenz
Generic Fixed Dose Combination (FDC) of Tenofovir(TDF) /Lamivudine(3TC)/Efavirenz (EFV) Tablets 300/300/600 mg

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.

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TDF/3TC/EFV demonstrated bioequivalent to original individual EFV 3TC and TDF in Indian healthy volunteers (unpublished data).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

Interventional
Phase 2
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
HIV
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.
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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
100
May 2015
May 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Thailand
 
NCT01160120
HIV-NAT 118
No
The HIV Netherlands Australia Thailand Research Collaboration
The HIV Netherlands Australia Thailand Research Collaboration
Matrix Laboratories Ltd
Principal Investigator: Anchalee Avihingsanon, MD, PhD The HIV Netherlands Australia Thailand Research Collaboration
The HIV Netherlands Australia Thailand Research Collaboration
March 2015

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