Pharmacogenomic of Atazanavir/Efavirenz (ATV/EFV)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

450 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-05-31

Study Completion Date

2010-12-31

Brief Summary

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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 correlate the genetic polymorphism/drug levels on antiretroviral toxicities

The long-term objective of this research plan is to characterize impact of pharmacogenomics to HIV drug concentration, toxicities, and response to antiretroviral therapy among HIV-infected adults. A comprehensive understanding of the impact of pharmacogenomics to HIV infection and HIV medication will lead to the development of appropriate intervention such as dose reduction strategies in patients with particular gene(s) correlated with higher drug levels. The dose reduction strategy will decrease long term drug toxicity and cost saving for Thais and Asian Ethnicities.

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Detailed Description

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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 Thailand. The specific aims are (1) to evaluate the impact of genetic polymorphism on ARV drug levels (2) to evaluate the effect of genetic polymorphism/ drug levels on long term immunologic and virologic response (3) to correlate the genetic polymorphism/drug levels on antiretroviral toxicities. The proposed study will be analysed in stored samples of the well-established cohort of long-term follow-up study for HIV-infected patients participated in HIV-NAT study protocols, the HIV-NAT006 study. This cohort provide us unique opportunity to study impact of pharmacogenomics on long term treatment response and long term drug toxicities since this cohort was started in 1996. Furthermore, the important factors include ARV regimen, drug toxicities, PBMC, immunological and virological parameters have been collected every 6 months basis in HIV-NAT006 study.

A comprehensive understanding of the impact of pharmacogenomics to HIV infection and HIV medication will lead to development of appropriate intervention, particularly, dose reduction strategy in patient with particular gene correlated with greater drug levels. The dose reduction strategy will decrease long term drug toxicity and cost saving for Thai and Asian Ethnicity.

Conditions

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HIV Infections

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

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

* 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

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No