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

• Status: Completed
• Trial end date: 2015-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The HIV Netherlands Australia Thailand Research Collaboration
• Collaborator: Mylan Laboratories
• Treatments: Efavirenz; Lamivudine; Tenofovir

Criteria

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