Ignite Creation Date:
2025-12-25 @ 4:11 AM
Ignite Modification Date:
2025-12-26 @ 3:09 AM
Study NCT ID:
NCT01160120
Status:
COMPLETED
Last Update Posted:
2020-07-17
First Post:
2010-06-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Therapeutic Drug Monitoring (TDM) in Generic Tenofovir/Lamivudine/Efavirenz
Sponsor:
The HIV Netherlands Australia Thailand Research Collaboration
Organization:
Study Overview
Official Title:
Generic Fixed Dose Combination (FDC) of Tenofovir(TDF) /Lamivudine(3TC)/Efavirenz (EFV) Tablets 300/300/600 mg
Status:
COMPLETED
Status Verified Date:
2020-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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/efavirenz tablets 300/300/600 mg in Thai HIV-infected patients.
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TDF/3TC/EFV demonstrated bioequivalent to original individual EFV 3TC and TDF in Indian healthy volunteers (unpublished data).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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: