Genotype Based Personalized Prescription of Nevirapine (GENPART)
|ClinicalTrials.gov Identifier: NCT00986063|
Recruitment Status : Completed
First Posted : September 29, 2009
Last Update Posted : April 22, 2013
Genetic tests has been suggested to reduce side effects related to Nevirapine(NVP), a commonly prescribed component of highly active antiretroviral therapy(HAART) in developing countries. This clinical trials is designed to determine the efficacy and the cost-effectiveness of this approach in the developing countries setting.
NVP-based HAART and efavirenz(EFV)-based HAART will be provided through Thai national universal health coverage. Information of the prescribed drug will be collected, and monitoring for the compliance with the prescribed highly active antiretroviral therapy will be conducted.
The primary objective of this study is to evaluate the reduction in incidences of NVP associated cutaneous side effects by genotype based personalized prescription. The volunteers will be monitored for any solicited and non-solicited adverse effects for 6 months after drug administration, with first 6 weeks intensive monitoring for cutaneous adverse reactions. Laboratory safety profiles (Complete Blood Count(CBC), Alanine transaminase(ALT), Aspartate transaminase(AST), Blood Urea Nitrogen(BUN), creatinine, direct bilirubin, total bilirubin, lactate dehydrogenase, alkaline phosphatase) will be assessed during the intensive monitoring period (6 weeks).
Descriptive statistics will be used to evaluate the conduct of the study. Analysis variables will include overall follow-up rate, drug compliance, and events of protocol violation.
Laboratory and safety data will be presented using comparative statistics for each study group and compared within and between groups using standard parametric or non-parametric comparison tests, i.e., McNemar's test or paired t-test as appropriate.
Comparison of rate of cutaneous adverse reaction, hepatitis and severe cutaneous adverse reaction(SCAR) will be made with chi-square test. Variable that shown significant different between the "standard of care" or control group and the "genetic test" or intervention group will adjusted for the final analysis with Poisson logistic regression.
The overall rate of adverse events in all participants will be monitored whether the rate of adverse events is lower than the predefined criteria. The extension of trial may be considered based on the rate of adverse events.
|Condition or disease||Intervention/treatment||Phase|
|Nevirapine Induced Rash Nevirapine Induced Hepatitis HIV Adverse Side Effects AIDS HIV Infections||Genetic: Genetic test for NVP induced rash Other: 3TC/D4T/NVP or 3TC/AZT/NVP||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Multi-center, Double-blinded Randomized Trial for Genotype Based Personalized Prescription of Nevirapine|
|Study Start Date :||July 2009|
|Actual Primary Completion Date :||July 2012|
|Actual Study Completion Date :||December 2012|
Active Comparator: Standard of care
AIDS patients taking care with standard of care
Other: 3TC/D4T/NVP or 3TC/AZT/NVP
Standard HAART for AIDS patients in Thailand
Experimental: Genetic test
AIDS patients who required highly active antiretroviral therapy(HAART) whom genotype status will be determined before initiation of HAART
Genetic: Genetic test for NVP induced rash
The genotype statuses that capable of predict the cutaneous side effects from nevirapine
- To compare the incidences of nevirapine associated rashes in patients who are initiated nevirapine guided by genetic tests (genetic test group) and patients who are initiated nevirapine using standard of care approach (control group). [ Time Frame: 6 months ]
- To determine the cost-effectiveness of genotyped based personalized prescription of nevirapine. [ Time Frame: 6 months ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00986063
|Division of Infectious Diseases, Department of Medicine, Faculty of Medicine Ramathibodi Hospital, Mahidol University|
|Bangkok, Thailand, 10400|
|Principal Investigator:||Somnuek Sungkanuparph, MD||Infectious disease Unit, Department of Internal Mediciine, Faculty of Ramathibodi Medical School, Mahidol University|