Nevirapine Induced RashPhase 4GENPARTNCT00986063
Genotype Based Personalized Prescription of Nevirapine
A Phase 4 study testing Genetic test for NVP induced rash and 3TC/D4T/NVP or 3TC/AZT/NVP in people with Nevirapine Induced Rash and Nevirapine Induced Hepatitis, run by Surakameth Mahasirimongkol at 1 site in Thailand.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nevirapine Induced Rash, Nevirapine Induced Hepatitis, HIV
- What is being tested?
- Genetic test for NVP induced rash and 3TC/D4T/NVP or 3TC/AZT/NVP
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,200 participants
- Where
- 1 siteThailand
- Study dates
- Jul 2009to Dec 2012
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Division of Infectious Diseases, Department of Medicine, Faculty of Medicine Ramathibodi Hospital, Mahidol University
Bangkok, Bangkok, 10400
About this study
Official title: A Multi-center, Double-blinded Randomized Trial for Genotype Based Personalized Prescription of Nevirapine
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.
Read more
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
- Being tested
- Genetic test for NVP induced rash, 3TC/D4T/NVP or 3TC/AZT/NVP
- Keywords
- Nevirapine induced rash, Hepatitis, Pharmacogenomics, AIDS, HIV, treatment naive
- Medical subject headings
- Acquired Immunodeficiency Syndrome, HIV Infections, Hepatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Genetic test for NVP induced rashGenetic
The genotype statuses that capable of predict the cutaneous side effects from nevirapine
3TC/D4T/NVP or 3TC/AZT/NVPOther
Standard HAART for AIDS patients in Thailand
| Study group | Role | What they receive |
|---|---|---|
| Standard of care | Active comparator | AIDS patients taking care with standard of care Receives: Other: 3TC/D4T/NVP or 3TC/AZT/NVP |
| Genetic test | Experimental | AIDS patients who required highly active antiretroviral therapy(HAART) whom genotype status will be determined before initiation of HAART Receives: Genetic: Genetic test for NVP induced rash |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 6 months
Secondary outcomes (1)
To determine the cost-effectiveness of genotyped based personalized prescription of nevirapine.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2009 (estimated)
- Study startJul 2009
- Primary completionJul 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nevirapine Induced RashStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Surakameth Mahasirimongkol
- Sponsor type
- University, hospital or other
- Collaborators
- Mahidol University, Chulalongkorn University, Thammasat University, Srinakharinwirot University, National Institutes of Health (NIH), RIKEN
- Responsible party
- Sponsor-investigator, Surakameth Mahasirimongkol, Mahidol University
- Investigators
- Somnuek Sungkanuparph, MD, Principal investigator, Infectious disease Unit, Department of Internal Mediciine, Faculty of Ramathibodi Medical School, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00986063
- Sponsor's protocol ID
- GENPART
- Acronym
- GENPART
- Status last verified
- Apr 2013
- First submitted
- 27 Sep 2009
- Last updated
- 22 Apr 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Double-blinded Randomized Trial for Genotype Based Personalized Prescription of Nevirapine
- ClinicalTrials.gov ID
- NCT00986063
- Acronym / sponsor ID
- GENPART / GENPART
- Conditions
- Nevirapine Induced Rash, Nevirapine Induced Hepatitis, HIV, Adverse Side Effects, AIDS, HIV Infections
- Keywords
- Nevirapine induced rash, Hepatitis, Pharmacogenomics, AIDS, HIV, treatment naive
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,200 participants (actual)
- Lead sponsor
- Surakameth MahasirimongkolUniversity, hospital or other
- Collaborators
- Mahidol University, Chulalongkorn University, Thammasat University, Srinakharinwirot University, National Institutes of Health (NIH), RIKEN
- Study start
- Jul 2009
- Primary completion
- Jul 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 29 Sep 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of care | Active comparator | Other: 3TC/D4T/NVP or 3TC/AZT/NVPAIDS patients taking care with standard of care |
| Genetic test | Experimental | Genetic: Genetic test for NVP induced rashAIDS patients who required highly active antiretroviral therapy(HAART) whom genotype status will be determined before initiation of HAART |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Genetic test for NVP induced rashThe genotype statuses that capable of predict the cutaneous side effects from nevirapine | Genetic | Genetic test |
| 3TC/D4T/NVP or 3TC/AZT/NVPStandard HAART for AIDS patients in Thailand | Other | Standard of care |
Primary outcome
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
1 secondary outcome
To determine the cost-effectiveness of genotyped based personalized prescription of nevirapine.
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2013.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Somnuek Sungkanuparph, MD principal investigator
Infectious disease Unit, Department of Internal Mediciine, Faculty of Ramathibodi Medical School, Mahidol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Genetic test for NVP induced rash and 3TC/D4T/NVP or 3TC/AZT/NVP in people with Nevirapine Induced Rash and Nevirapine Induced Hepatitis, run by Surakameth Mahasirimongkol at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2013.