drugset / Trial / NCT01160120
Therapeutic Drug Monitoring (TDM) in Generic Tenofovir/Lamivudine/Efavirenz
Phase 2
Completed
100 enrolled
The HIV Netherlands Australia Thailand Research Collaboration
Mylan Laboratories · collab
NaSingle-groupOpen-labelOther
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.
Timeline
- Start
- 2010-06
- Primary completion
- 2013-05
- Completion
- 2015-06
Publications
- Results Avihingsanon A, Sophonphan J, Thammajaruk N, Chaihong P, Burger D, Cressey TR, Ramautarsing RA, Praditornsilpa K, Avihingsanon Y, Ruxrungtham K and HIV-NAT 114 study team. Plasma Tenofovir Concentrations and Proximal Tubular Dysfunction in HIV-Infected Adults Receiving Tenofovir in Thailand. AIDS Clin Res 2015, 6:7 Doi: http://dx.doi.org/10.4172/2155-6113.1000477
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | TDF/3TC/EFV | Unknown | 300 mg | Oral |
| Subject | TDF/3TC/EFV | Unknown | 600 mg | Oral |