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
• Sponsor: Surakameth Mahasirimongkol
• 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: September 27, 2009
• First Posted Date: September 29, 2009
• Last Update Posted Date: April 22, 2013
• Study Start Date: July 2009
• Actual Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (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: Same as current
• Current Secondary Outcome Measures (submitted: September 28, 2009): To determine the cost-effectiveness of genotyped based personalized prescription of nevirapine. [ Time Frame: 6 months ]
• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Genotype Based Personalized Prescription of Nevirapine
• Official Title: 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: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Prevention

Condition

• Nevirapine Induced Rash
• Nevirapine Induced Hepatitis
• HIV
• Adverse Side Effects
• AIDS
• HIV Infections

Intervention

• 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

• 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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: April 19, 2013): 1200
• Original Estimated Enrollment (submitted: September 28, 2009): 2200
• Actual Study Completion Date: December 2012
• Actual Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Thailand

Administrative Information

• NCT Number: NCT00986063
• Other Study ID Numbers: GENPART
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Surakameth Mahasirimongkol, Mahidol University
• Study Sponsor: Surakameth Mahasirimongkol

Collaborators

• Mahidol University
• Chulalongkorn University
• Thammasat University
• Srinakharinwirot University
• National Institutes of Health (NIH)
• RIKEN

Investigators

• 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