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Genotype Based Personalized Prescription of Nevirapine (GENPART)

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ClinicalTrials.gov Identifier: NCT00986063
Recruitment Status : Completed
First Posted : September 29, 2009
Last Update Posted : April 22, 2013
Sponsor:
Collaborators:
Mahidol University
Chulalongkorn University
Thammasat University
Srinakharinwirot University
National Institutes of Health (NIH)
RIKEN
Information provided by (Responsible Party):
Surakameth Mahasirimongkol, Mahidol University

Tracking Information
First Submitted Date  ICMJE September 27, 2009
First Posted Date  ICMJE September 29, 2009
Last Update Posted Date April 22, 2013
Study Start Date  ICMJE July 2009
Actual Primary Completion Date July 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 28, 2009)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 28, 2009)
To determine the cost-effectiveness of genotyped based personalized prescription of nevirapine. [ Time Frame: 6 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Genotype Based Personalized Prescription of Nevirapine
Official Title  ICMJE A Multi-center, Double-blinded Randomized Trial for Genotype Based Personalized Prescription of Nevirapine
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Nevirapine Induced Rash
  • Nevirapine Induced Hepatitis
  • HIV
  • Adverse Side Effects
  • AIDS
  • HIV Infections
Intervention  ICMJE
  • Genetic: Genetic test for NVP induced rash
    The genotype statuses that capable of predict the cutaneous side effects from nevirapine
  • Other: 3TC/D4T/NVP or 3TC/AZT/NVP
    Standard HAART for AIDS patients in Thailand
Study Arms  ICMJE
  • Active Comparator: Standard of care
    AIDS patients taking care with standard of care
    Intervention: Other: 3TC/D4T/NVP or 3TC/AZT/NVP
  • Experimental: Genetic test
    AIDS patients who required highly active antiretroviral therapy(HAART) whom genotype status will be determined before initiation of HAART
    Intervention: Genetic: Genetic test for NVP induced rash
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 19, 2013)
1200
Original Estimated Enrollment  ICMJE
 (submitted: September 28, 2009)
2200
Actual Study Completion Date  ICMJE December 2012
Actual Primary Completion Date July 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Thailand
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00986063
Other Study ID Numbers  ICMJE GENPART
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Surakameth Mahasirimongkol, Mahidol University
Study Sponsor  ICMJE Surakameth Mahasirimongkol
Collaborators  ICMJE
  • Mahidol University
  • Chulalongkorn University
  • Thammasat University
  • Srinakharinwirot University
  • National Institutes of Health (NIH)
  • RIKEN
Investigators  ICMJE
Principal Investigator: Somnuek Sungkanuparph, MD Infectious disease Unit, Department of Internal Mediciine, Faculty of Ramathibodi Medical School, Mahidol University
PRS Account Mahidol University
Verification Date April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP