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

T

The HIV Netherlands Australia Thailand Research Collaboration

Status and phase

Completed
Phase 2

Conditions

HIV

Treatments

Drug: generic FDC of TDF/3TC/EFV

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT01160120
HIV-NAT 118

Details and patient eligibility

About

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.

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TDF/3TC/EFV demonstrated bioequivalent to original individual EFV 3TC and TDF in Indian healthy volunteers (unpublished data).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

Enrollment

100 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

100 participants in 1 patient group

1
Other group
Description:
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.
Treatment:
Drug: generic FDC of TDF/3TC/EFV

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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