Status:
COMPLETED
Genotype Based Personalized Prescription of Nevirapine
Lead Sponsor:
Surakameth Mahasirimongkol
Collaborating Sponsors:
Mahidol University
Chulalongkorn University
Conditions:
Nevirapine Induced Rash
Nevirapine Induced Hepatitis
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 clinica...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
1200 Patients enrolled
Trial Details
Trial ID
NCT00986063
Start Date
July 1 2009
End Date
December 1 2012
Last Update
April 22 2013
Active Locations (1)
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1
Division of Infectious Diseases, Department of Medicine, Faculty of Medicine Ramathibodi Hospital, Mahidol University
Bangkok, Bangkok, Thailand, 10400