Status:
COMPLETED
Pharmacogenomic of Atazanavir/Efavirenz (ATV/EFV)
Lead Sponsor:
The HIV Netherlands Australia Thailand Research Collaboration
Collaborating Sponsors:
Chulalongkorn University
Kirby Institute
Conditions:
HIV Infections
Eligibility:
All Genders
18+ years
Brief Summary
Objectives: * To evaluate the impact of genetic polymorphism on ARV drug levels * To evaluate the effect of genetic polymorphism/drug levels on long term immunologic and virologic response * To corre...
Detailed Description
The overall goal of this study is to characterize role of pharmacogenomic on ARV drug (atazanavir, and efavirenz) levels, its toxicities, and its long term efficacy among HIV-infected adults in Thaila...
Eligibility Criteria
Inclusion
- Inclusion criteria for pharmacogenomic of ATV:
- On low-dose ATV/r at the time blood samples are collected for ATV drug levels
- Age \> 18 years of age or older with HIV-1 infection
- 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
- Exclusion criteria for both ATV and EFV
- Inability to understand the nature and extent of the study and the procedures required.
- Contramedication such as rifampin, proton pump inhibitor (for ATV), etc
- Pregnancy during blood drawn for EFV or ATV drug levels
- Known renal insufficiency or cirrhosis during blood drawn for EFV or ATV drug levels
Key Trial Info
Start Date :
May 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
450 Patients enrolled
Trial Details
Trial ID
NCT01138267
Start Date
May 1 2009
End Date
December 1 2010
Last Update
July 17 2020
Active Locations (1)
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1
HIV-NAT Thai Red Cross AIDS Research Center
Bangkok, Thailand, 10330