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

PHASE2CompletedINTERVENTIONAL
Enrollment

100

Participants

Timeline

Start Date

June 30, 2010

Primary Completion Date

May 31, 2013

Study Completion Date

June 30, 2015

Conditions
HIV
Interventions
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.

Trial Locations (1)

10330

HIV-NAT, Bangkok

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Mylan Laboratories

INDUSTRY

lead

The HIV Netherlands Australia Thailand Research Collaboration

OTHER