Genotype Based Personalized Prescription of Nevirapine

NCT ID: NCT00986063

Last Updated: 2013-04-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 1200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-07-31
• Study Completion Date: 2012-12-31

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Standard of care

AIDS patients taking care with standard of care

Group Type: ACTIVE_COMPARATOR

3TC/D4T/NVP or 3TC/AZT/NVP

Intervention Type: OTHER

Standard HAART for AIDS patients in Thailand

Genetic test

AIDS patients who required highly active antiretroviral therapy(HAART) whom genotype status will be determined before initiation of HAART

Group Type: EXPERIMENTAL

Genetic test for NVP induced rash

Intervention Type: GENETIC

The genotype statuses that capable of predict the cutaneous side effects from nevirapine

Interventions

Genetic test for NVP induced rash

The genotype statuses that capable of predict the cutaneous side effects from nevirapine

Intervention Type: GENETIC

3TC/D4T/NVP or 3TC/AZT/NVP

Standard HAART for AIDS patients in Thailand

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mahidol University

OTHER

Sponsor Role: collaborator

Chulalongkorn University

OTHER

Sponsor Role: collaborator

Thammasat University

OTHER

Sponsor Role: collaborator

Srinakharinwirot University

OTHER

Sponsor Role: collaborator

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

RIKEN

OTHER

Sponsor Role: collaborator

Surakameth Mahasirimongkol

OTHER

Sponsor Role: lead

Responsible Party

Surakameth Mahasirimongkol

Dr.

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Somnuek Sungkanuparph, MD

Role: PRINCIPAL_INVESTIGATOR

Infectious disease Unit, Department of Internal Mediciine, Faculty of Ramathibodi Medical School, Mahidol University

Locations

Division of Infectious Diseases, Department of Medicine, Faculty of Medicine Ramathibodi Hospital, Mahidol University

Bangkok, Bangkok, Thailand

Countries

Thailand

Other Identifiers

GENPART

Identifier Type: -

Identifier Source: org_study_id