HIV
Conditions
Keywords
fixed dose combinations, tenofovir, lamivudine, efavirenz, therapeutic drug levels, safety and efficacy, HIV, To evaluation new formulations of FDC of TDF/3TC/EFV
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TDF/3TC/EFV demonstrated bioequivalent to original individual EFV 3TC and TDF in Indian healthy volunteers (unpublished data).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.
Interventions
DRUGgeneric FDC of TDF/3TC/EFV
Patients who were on individual TDF 3TC and EFV regimen before baseline will undergo TDM at baseline. Therapeutic drug monitoring (TDM) of generic FDC of TDF/3TC/EFV will be done after 4 weeks, to ensure steady state. At baseline and week 4 safety data will be obtained. In order to assess the efficacy and the long term safety of this drug, at week 12, 24 and 48 viral load, CD4 and safety parameters will be obtained.
Sponsors
Mylan Laboratories
The HIV Netherlands Australia Thailand Research Collaboration
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| mid levels of TDF, 3TC, and EFV between brand and generic | 144 weeks | mid levels of TDF, 3TC, and EFV between brand and generic |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| kidney, liver, CD4 and viral load overtime | 144 weeks | kidney, liver, CD4 and viral load overtime |
Countries
Thailand
Outcome results
None listed