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Genotype Based Personalized Prescription of Nevirapine (GENPART)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00986063
Recruitment Status : Completed
First Posted : September 29, 2009
Last Update Posted : April 22, 2013
Mahidol University
Chulalongkorn University
Thammasat University
Srinakharinwirot University
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Surakameth Mahasirimongkol, Mahidol University

Brief Summary:

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.

Outcome measurements:

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).

Statistical Methods:

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Genetic Testing
Drug Information available for: Nevirapine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. To determine the cost-effectiveness of genotyped based personalized prescription of nevirapine. [ Time Frame: 6 months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Male and female (non-lactating and non-pregnant), aged between 18-70 years
  • Written informed consent given after reading the volunteer information leaflet. Participation will be voluntary and volunteers will be fully informed of possible side effects. They will be advised that they are free to withdraw at any time.
  • Has confirmed human immunodeficiency virus type 1 infection.
  • Require antiretroviral based on standard practice guideline in Thailand.
  • Adequate venous access
  • Naïve to antiretroviral therapy standard clinical guideline in Thailand.
  • Give consent to determine the genotype status

Exclusion Criteria:

  • Women who are breast-feeding
  • Participation in a study of any investigational drug where the study drug was received within the last 30 days
  • Patients who received post or pre-exposure prophylaxis or single dose peripartum prevention incorporated of NVP will be excluded

Information from the National Library of Medicine

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 identifier (NCT number): NCT00986063

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Division of Infectious Diseases, Department of Medicine, Faculty of Medicine Ramathibodi Hospital, Mahidol University
Bangkok, Thailand, 10400
Sponsors and Collaborators
Surakameth Mahasirimongkol
Mahidol University
Chulalongkorn University
Thammasat University
Srinakharinwirot University
National Institutes of Health (NIH)
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Principal Investigator: Somnuek Sungkanuparph, MD Infectious disease Unit, Department of Internal Mediciine, Faculty of Ramathibodi Medical School, Mahidol University
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Responsible Party: Surakameth Mahasirimongkol, Dr., Mahidol University Identifier: NCT00986063    
Other Study ID Numbers: GENPART
First Posted: September 29, 2009    Key Record Dates
Last Update Posted: April 22, 2013
Last Verified: April 2013
Keywords provided by Surakameth Mahasirimongkol, Mahidol University:
Nevirapine induced rash
treatment naive
Additional relevant MeSH terms:
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Liver Diseases
Digestive System Diseases