Pharmacogenomic of Atazanavir/Efavirenz (ATV/EFV)
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| ClinicalTrials.gov Identifier: NCT01138267 |
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Recruitment Status
:
Completed
First Posted
: June 7, 2010
Last Update Posted
: February 7, 2011
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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.
| Condition or disease |
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| HIV Infections |
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.
| Study Type : | Observational |
| Estimated Enrollment : | 450 participants |
| Observational Model: | Cohort |
| Time Perspective: | Retrospective |
| Official Title: | Impact of Pharmacogenomics on Antiretroviral Drugs (Atazanavir and Efavirenz) Concentration and Treatment Response in HIV-infected Adults Study-team |
| Study Start Date : | May 2009 |
| Actual Primary Completion Date : | December 2010 |
| Actual Study Completion Date : | December 2010 |
- Frequency of MDR1-3435 allele variants,MDR1-2677 allele variants,UGT1A1 allele variants, frequency of CYP 2B6 variants in efavirenz treatment and compare candidate gene and treatment response of ATV/r or EFV [ Time Frame: 2 years ]
- Compare drug conc. of UGT1A1 variant with bilirubin, drug conc. & treatment resp. of ATV/r or EFV, drug conc.for WT, drug conc.for 2B6 variant with EFV toxicity & drug discontinuation, drug conc.or 2B6 variant with long term efficacy & EFV resistance [ Time Frame: 2 years ]
Biospecimen Retention: Samples With DNA
Patients are divided into 4 groups based on whether they need to redraw their blood.
- have adequate samples stored and do not need additional blood draws.
- have EFV or ATV blood concentrations samples stored but do not have samples for genotyping. Need extra 5-ml sample.
- have samples stored but the samples cannot be used to test for EFV or ATV blood concentrations because the time of drug intake and blood drawn are unknown. Need to redraw 5-ml sample.
- have never had both drug concentration and genotyping done. Need to give 10 ml of blood sample to perform both tests.
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| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
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 Criteria:
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01138267
| Thailand | |
| HIV-NAT Thai Red Cross AIDS Research Center | |
| Bangkok, Thailand, 10330 | |
| Principal Investigator: | Kiat Ruxrungtham, MD | Chulalongkorn University |
Additional Information:
| Responsible Party: | Prof Kiat Ruxrungtham, Chulalongkorn University |
| ClinicalTrials.gov Identifier: | NCT01138267 History of Changes |
| Other Study ID Numbers: |
HIV-NAT103 |
| First Posted: | June 7, 2010 Key Record Dates |
| Last Update Posted: | February 7, 2011 |
| Last Verified: | February 2011 |
Keywords provided by The HIV Netherlands Australia Thailand Research Collaboration:
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pharmacogenomics ATV EFV pharmacogenomics of ATV and EFV |
Additional relevant MeSH terms:
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HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Efavirenz Atazanavir Sulfate Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors |
Molecular Mechanisms of Pharmacological Action Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Cytochrome P-450 CYP2C9 Inhibitors Cytochrome P-450 Enzyme Inhibitors Cytochrome P-450 CYP2C19 Inhibitors Cytochrome P-450 CYP2B6 Inducers Cytochrome P-450 Enzyme Inducers Cytochrome P-450 CYP3A Inducers HIV Protease Inhibitors Protease Inhibitors Anti-HIV Agents |