Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00032669
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
2002-03-27
Brief Title:
Therapeutic Drug Monitoring and Viral Resistance Testing in the Treatment of HIV-Infected Children
Sponsor:
National Cancer Institute NCI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Therapeutic Drug Monitoring and Viral Resistance Testing in the Treatment of HIV-Infected Children
Status:
COMPLETED
Status Verified Date:
2006-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will evaluate a new treatment strategy called therapeutic drug monitoring TDM in HIV-infected children and adolescents TDM involves analyzing the virus giving drugs the virus is most sensitive to monitoring drug blood levels to make sure there is enough drug to work against the virus and changing the drug dose if it is too low
HIV-infected children between 0 and 21 years of age who may benefit from treatment with a protease inhibitor and who are not benefiting from their current antiretroviral drug treatment regimen may be enrolled in this 48-week study Patients who are not currently receiving antiretroviral treatment including patients who have never received antiretroviral treatment may be enrolled in the study
Participants will have blood drawn to learn what anti-HIV drugs the patients virus is resistant to-that is what drugs are no longer effective against the virus This is determined by analyzing the viruss genotype detailed genetic structure and phenotype response to exposure to anti-viral drugs Based on these test results and the patients prior medication history a drug regimen tailored to the individual patient will be prescribed It may include one or two nucleoside reverse transcriptase inhibitors such as zidovudine didanosine lamuvidine zalcitabine stavudine a non- nucleoside reverse transcriptase inhibitor such as nevirapine or efavirenz and a protease inhibitor such as amprenavir nelfinavir saquinavir ritonavir or Kaletra a combination of lopinavir and ritonavir
After the patients begin treatment the amount of the protease inhibitor in the blood will be measured If not enough of the drug is found in the blood the dose of the drug will be increased and the amount of the drug in the blood will be checked again In this study the dose may be increased up to three times
Patients will be seen in clinic for 6 days when treatment begins to measure blood levels of the medicines and evaluate the response of the virus Treatment will then continue on an outpatient basis Drug levels will be measured periodically throughout the study The viral load will also be measured and additional tests to determine whether the resistance pattern of the patients virus has changed In addition patients will undergo the following tests and procedures at various times throughout the study more frequently for the first few months and then less often
Blood tests to measure cell counts and viral load
Routine laboratory tests to measure kidney liver bone marrow and other organ functioning
Eye and neuropsychologic examinations
Echocardiogram heart ultrasound
Electrocardiogram EKG - heart rhythm test
Chest X-ray
Computed tomography CT scan of the head
Skin tests
To make sure the medicines work they must be taken as directed In addition since higher than usual doses of some of the anti-HIV drugs may be given it will be important to know whether the patients are taking all of the medicine that has been prescribed This study will therefore also measure patients adherence to their medication regimen in two ways 1 some medicines will be packaged in a bottle with an electronic medicine bottle cap that will record when the bottle is opened and 2 patients and their parents will be interviewed by phone or in person at various times during the study about adherence and may be asked to fill out forms that record the number of doses taken This will allow the doctor and patient to work together to make sure the medicines are being taken properly Patients and parents will also be interviewed periodically about their understanding of HIV disease about social supports that are available and about the childs emotional adjustment
HIV-infected children between 0 and 21 years of age who may benefit from treatment with a protease inhibitor and who are not benefiting from their current antiretroviral drug treatment regimen may be enrolled in this 48-week study Patients who are not currently receiving antiretroviral treatment including patients who have never received antiretroviral treatment may be enrolled in the study
Participants will have blood drawn to learn what anti-HIV drugs the patients virus is resistant to-that is what drugs are no longer effective against the virus This is determined by analyzing the viruss genotype detailed genetic structure and phenotype response to exposure to anti-viral drugs Based on these test results and the patients prior medication history a drug regimen tailored to the individual patient will be prescribed It may include one or two nucleoside reverse transcriptase inhibitors such as zidovudine didanosine lamuvidine zalcitabine stavudine a non- nucleoside reverse transcriptase inhibitor such as nevirapine or efavirenz and a protease inhibitor such as amprenavir nelfinavir saquinavir ritonavir or Kaletra a combination of lopinavir and ritonavir
After the patients begin treatment the amount of the protease inhibitor in the blood will be measured If not enough of the drug is found in the blood the dose of the drug will be increased and the amount of the drug in the blood will be checked again In this study the dose may be increased up to three times
Patients will be seen in clinic for 6 days when treatment begins to measure blood levels of the medicines and evaluate the response of the virus Treatment will then continue on an outpatient basis Drug levels will be measured periodically throughout the study The viral load will also be measured and additional tests to determine whether the resistance pattern of the patients virus has changed In addition patients will undergo the following tests and procedures at various times throughout the study more frequently for the first few months and then less often
Blood tests to measure cell counts and viral load
Routine laboratory tests to measure kidney liver bone marrow and other organ functioning
Eye and neuropsychologic examinations
Echocardiogram heart ultrasound
Electrocardiogram EKG - heart rhythm test
Chest X-ray
Computed tomography CT scan of the head
Skin tests
To make sure the medicines work they must be taken as directed In addition since higher than usual doses of some of the anti-HIV drugs may be given it will be important to know whether the patients are taking all of the medicine that has been prescribed This study will therefore also measure patients adherence to their medication regimen in two ways 1 some medicines will be packaged in a bottle with an electronic medicine bottle cap that will record when the bottle is opened and 2 patients and their parents will be interviewed by phone or in person at various times during the study about adherence and may be asked to fill out forms that record the number of doses taken This will allow the doctor and patient to work together to make sure the medicines are being taken properly Patients and parents will also be interviewed periodically about their understanding of HIV disease about social supports that are available and about the childs emotional adjustment
Detailed Description:
This is a single arm study to determine whether a novel dose adjustment strategy that individualizes protease inhibitor dosing to maintain drug concentrations above virologic-based threshold values TDM in pediatric patients with HIV is able to result in a potentially clinically useful proportion of patients who achieve a targeted inhibitory quotient IQ The study will consist of up to 34 children between 0 and 21 years of age minimum weight 10 kg Patients will have viral resistance testing performed at baseline and that information combined with treatment history analysis and drug tolerability issues will be used to design a combination antiretroviral regimen After the new regimen is started pharmacokinetic monitoring will guide dose adjustments of protease inhibitors An algorithm will be followed to make dose adjustments based upon viral phenotype and drug levels The primary outcome measure will be the fraction of patients who attain adequate protease inhibitor levels above target values Secondary measures will include virologic and immunologic benefits and evaluation of toxicity and tolerability
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 02-C-0150 | None | None | None |