Trial record 3 of 50 for:    " September 02, 2009":" October 02, 2009"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]

Genotype Based Personalized Prescription of Nevirapine (GENPART)

This study has been completed.
Sponsor:
Collaborators:
Mahidol University
Chulalongkorn University
Thammasat University
Srinakharinwirot University
RIKEN
Information provided by (Responsible Party):
Surakameth Mahasirimongkol, Mahidol University
ClinicalTrials.gov Identifier:
NCT00986063
First received: September 27, 2009
Last updated: April 19, 2013
Last verified: April 2013
  Purpose

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 Intervention 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
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Multi-center, Double-blinded Randomized Trial for Genotype Based Personalized Prescription of Nevirapine

Resource links provided by NLM:


Further study details as provided by Mahidol University:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To determine the cost-effectiveness of genotyped based personalized prescription of nevirapine. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 1200
Study Start Date: July 2009
Study Completion Date: December 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00986063

Locations
Thailand
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
RIKEN
Investigators
Principal Investigator: Somnuek Sungkanuparph, MD Infectious disease Unit, Department of Internal Mediciine, Faculty of Ramathibodi Medical School, Mahidol University
  More Information

No publications provided

Responsible Party: Surakameth Mahasirimongkol, Dr., Mahidol University
ClinicalTrials.gov Identifier: NCT00986063     History of Changes
Other Study ID Numbers: GENPART
Study First Received: September 27, 2009
Last Updated: April 19, 2013
Health Authority: Thailand: Food and Drug Administration

Keywords provided by Mahidol University:
Nevirapine induced rash
Hepatitis
Pharmacogenomics
AIDS
HIV
treatment naive

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Exanthema
Hepatitis
Hepatitis A
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Skin Diseases
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Enterovirus Infections
Picornaviridae Infections
Nevirapine
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 26, 2014