Pharmacogenomic of Atazanavir/Efavirenz (ATV/EFV)

Plain-language summary

This study looks at how genetic factors influence the blood levels of the HIV medications Atazanavir and Efavirenz in people with HIV-1 infection. It included adults over 18 years of age living with HIV-1 infection. It was carried out as a study with no assigned phase and has been completed.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

N/A

Status

Completed

Sponsor

The HIV Netherlands Australia Thailand Research Collaboration

Start date

5/1/2009

Estimated completion

12/1/2010

Countries

Thailand

Related genes

Locations

• Bangkok, Thailand

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

Inclusion Criteria:

Inclusion criteria for pharmacogenomic of ATV:

1. On low-dose ATV/r at the time blood samples are collected for ATV drug levels
2. Age \> 18 years of age or older with HIV-1 infection
3. Provided consent form

Inclusion criteria for pharmacogenomic of EFV:

* On EFV at the time blood samples are collected for EFV levels
* Age \> 18 years of age or older with HIV-1 infection
* Patients who were on EFV but later switched to another ARV regimen due to toxicity of EFV and have stored sample at time of taking EFV
* Provided consent form

Exclusion Criteria:

Exclusion criteria for both ATV and EFV

1. Inability to understand the nature and extent of the study and the procedures required.
2. Contramedication such as rifampin, proton pump inhibitor (for ATV), etc
3. Pregnancy during blood drawn for EFV or ATV drug levels
4. Known renal insufficiency or cirrhosis during blood drawn for EFV or ATV drug levels