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HIV

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

Sponsored by The HIV Netherlands Australia Thailand Research Collaboration

About this trial

Last updated 5 years ago

Study ID

HIV-NAT 118

Status

Completed

Type

Interventional

Phase

Phase 2

Placebo

No

Accepting

18-75 Years
18+ Years
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Ended 10 years ago

What is this trial about?

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.

What are the participation requirements?

Yes

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

No

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

Locations

Location

Status