Therapeutic Drug Monitoring (TDM) in Generic Tenofovir/Lamivudine/Efavirenz

HIV Clinical Trial

Official title:

Generic Fixed Dose Combination (FDC) of Tenofovir(TDF) /Lamivudine(3TC)/Efavirenz (EFV) Tablets 300/300/600 mg

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01160120
• Other study ID #: HIV-NAT 118
• Status: Completed
• Phase: Phase 2
• Start date: June 2010
• Est. completion date: June 2015

Study information

• Verified date: July 2020
• Source: The HIV Netherlands Australia Thailand Research Collaboration
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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TDF/3TC/EFV demonstrated bioequivalent to original individual EFV 3TC and TDF in Indian healthy volunteers (unpublished data).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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: June 2015
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• HIV

Intervention

Drug:
• generic 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.

Locations

Country	Name	City	State
Thailand	HIV-NAT	Bangkok

Sponsors (2)

Lead Sponsor	Collaborator
The HIV Netherlands Australia Thailand Research Collaboration	Mylan Laboratories

Country where clinical trial is conducted

Thailand, 

References & Publications (1)

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 Ad

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	mid levels of TDF, 3TC, and EFV between brand and generic	mid levels of TDF, 3TC, and EFV between brand and generic	144 weeks
Secondary	kidney, liver, CD4 and viral load overtime	kidney, liver, CD4 and viral load overtime	144 weeks

External Links

•   HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT)