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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 patient's virus is resistant to-that is, what drugs are no longer effective against the virus. This is determined by analyzing the virus's genotype (detailed genetic structure) and phenotype (response to exposure to anti-viral drugs). Based on these test results and the patient's 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 child's emotional adjustment.
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.
Endpoint Classification: Safety Study, Primary Purpose: Treatment
National Cancer Institute (NCI)
National Institutes of Health Clinical Center (CC)
Published on BioPortfolio: 2014-08-27T03:56:17-0400
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