Status:
COMPLETED
Therapeutic Drug Monitoring (TDM) in Generic Tenofovir/Lamivudine/Efavirenz
Lead Sponsor:
The HIV Netherlands Australia Thailand Research Collaboration
Collaborating Sponsors:
Mylan Laboratories
Conditions:
HIV
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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/e...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2015
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT01160120
Start Date
June 1 2010
End Date
June 1 2015
Last Update
July 17 2020
Active Locations (1)
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1
HIV-NAT
Bangkok, Thailand, 10330