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

NCT01160120 | Completed Phase 2

• 1 other identifier: HIV-NAT 118
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV

Keywords

fixed dose combinations; tenofovir; lamivudine; efavirenz; therapeutic drug levels; safety and efficacy; HIV; To evaluation new formulations of FDC of TDF/3TC/EFV

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• kidney, liver, CD4 and viral load overtime

  144 weeks

Study Arms (1)

1

OTHER

Patients can be either treatment-naïve or treatment-experienced when entering this clinical trial. After meeting the inclusion and exclusion criteria, patients will start with generic FDC of TDF/3TC/EFV 1 pill a day at night time. Only patient who are on individual TDF 3TC and EFV will undergo TDM sampling ( 11-13 hours after dosing) at baseline.

Drug: generic FDC of TDF/3TC/EFV

Interventions

generic FDC of TDF/3TC/EFV DRUG

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.

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The HIV Netherlands Australia Thailand Research Collaboration: lead
• Mylan Laboratories: collaborator

Study Sites (1)

HIV-NAT

Bangkok, 10330, Thailand

Location

Related 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 Adults Receiving Tenofovir in Thailand. AIDS Clin Res 2015, 6:7 Doi: http://dx.doi.org/10.4172/2155-6113.1000477

  RESULT

Related Links

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

Study Officials

• Anchalee Avihingsanon, MD, PhD

  The HIV Netherlands Australia Thailand Research Collaboration

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2010
• First Posted: July 12, 2010
• Study Start: June 1, 2010
• Primary Completion: May 1, 2013
• Study Completion: June 1, 2015
• Last Updated: July 17, 2020

Record last verified: 2020-07

Locations

TH (1)