Therapeutic Drug Monitoring (TDM) in Generic Tenofovir/Lamivudine/Efavirenz
Information source: The HIV Netherlands Australia Thailand Research Collaboration
Information obtained from ClinicalTrials.gov on February 07, 2013
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: HIV Infections
Intervention: generic FDC of TDF/3TC/EFV (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: The HIV Netherlands Australia Thailand Research Collaboration Official(s) and/or principal investigator(s):
Kiat Ruxrungtham, MD, Principal Investigator, Affiliation: The HIV Netherlands Australia Thailand Research Collaboration
Overall contact:
Anchalee Avihingsanon, MD, Phone: 662-652-3040, Ext: 107, Email: anchalee.a@hivnat.org
Summary
The purpose of this study is to determine the mid levels of the tenofovir, lamivudine, and
efavirenz, and 48 weeks safety and efficacy of the generic fixed dose combination of
tenofovir /lamivudine/efavirenz tablets 300/300/600 mg in Thai HIV-infected patients.
Clinical Details
Official title: Generic Fixed Dose Combination (FDC) of Tenofovir(TDF) /Lamivudine(3TC)/Efavirenz (EFV) Tablets 300/300/600 mg
Study design: Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label
Primary outcome: mid levels of TDF, 3TC, and EFV between brand and generic
Secondary outcome: kidney, liver, CD4 and viral load overtime
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 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original individual EFV 3TC and TDF in Indian healthy volunteers (unpublished data).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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Anchalee Avihingsanon, MD, Phone: 662-652-3040, Ext: 107, Email: anchalee.a@hivnat.org
HIV-NAT, Bangkok 10330, Thailand; Recruiting
Anchalee Avihingsanon, MD, Phone: 662-652-3040, Ext: 107, Email: anchalee.a@hivnat.org
Thidarat Jupimai, BS, Phone: 662-652-3040, Ext: 127, Email: thidarat.j@hivnat.org
Kiat Ruxrungtham, MD, Principal Investigator
Additional Information
HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT)
Starting date: June 2010
Last updated: February 3, 2011
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