Ignite Creation Date:
2024-05-05 @ 11:08 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006519
Status:
COMPLETED
Last Update Posted:
2006-07-11
First Post:
2000-11-23
Brief Title:
Capravirine to Treat Children With HIV Infection
Sponsor:
National Cancer Institute NCI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
A Phase I Study of Capravirine AG 1549 a Novel Non-Nucleoside Reverse Transcriptase Inhibitor in Children With HIV Infection
Status:
COMPLETED
Status Verified Date:
2004-10
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 test the safety side effects and anti-HIV activity of different doses of capravirine in children and adolescents with HIV infection Capravirine belongs to a class of drugs called non-nucleoside reverse transcriptase inhibitors NNRTIs which prevent the virus from replicating making more copies of itself Other NNRTIs are nevirapine delavirdine and efavirenz
HIV-infected children between the ages of 4 months and 21 years may be eligible for this study if they 1 have received less than 6 weeks of treatment with antiretroviral drugs 2 have not benefited from antiretroviral therapy after 12 weeks of treatment 3 cannot continue antiretroviral treatment because of harmful side effects
For the first week of the study participants will have a 1-week washout period in which they will receive no anti-HIV therapy During this time they will have physical eye and neuropsychologic examinations blood and urine tests echocardiogram electrocardiogram EKG chest X-ray head CT scan and skin tests These physical exams and tests will be repeated throughout the study to determine changes in health
After the washout period patients will take capravirine once a day in the morning for 6 days After each dose a small amount of blood will be drawn at 8 different times over 12 hours to measure the activity of the drug and HIV blood levels A heparin lock will be placed in the vein to avoid multiple needlesticks After the 6 days of capravirine there will be another washout period this time for 21 days During this time doctors will determine the optimum combination therapy for the individual patient
After the second washout patients will begin combination therapy with capravirine plus at least two other anti-HIV medicines These may include a reverse transcriptase inhibitor such as zidovudine didanosine lamuvidine zalcitabine or stavudine and maybe one or more protease inhibitors such as ritonavir nelfinavir saquinavir indinavir or amprenavir For the first week patients will have a daily blood test to determine HIV blood levels Afterwards treatment will continue on an outpatient basis with clinic visits every 4 to 8 weeks for physical exams lab tests and other procedures as required The study will last approximately 48 weeks Patients who benefit from capravirine therapy may be able to continue to receive the drug from the drug company sponsor or as part of another study or the protocol for this study may be amended to lengthen the treatment period
HIV-infected children between the ages of 4 months and 21 years may be eligible for this study if they 1 have received less than 6 weeks of treatment with antiretroviral drugs 2 have not benefited from antiretroviral therapy after 12 weeks of treatment 3 cannot continue antiretroviral treatment because of harmful side effects
For the first week of the study participants will have a 1-week washout period in which they will receive no anti-HIV therapy During this time they will have physical eye and neuropsychologic examinations blood and urine tests echocardiogram electrocardiogram EKG chest X-ray head CT scan and skin tests These physical exams and tests will be repeated throughout the study to determine changes in health
After the washout period patients will take capravirine once a day in the morning for 6 days After each dose a small amount of blood will be drawn at 8 different times over 12 hours to measure the activity of the drug and HIV blood levels A heparin lock will be placed in the vein to avoid multiple needlesticks After the 6 days of capravirine there will be another washout period this time for 21 days During this time doctors will determine the optimum combination therapy for the individual patient
After the second washout patients will begin combination therapy with capravirine plus at least two other anti-HIV medicines These may include a reverse transcriptase inhibitor such as zidovudine didanosine lamuvidine zalcitabine or stavudine and maybe one or more protease inhibitors such as ritonavir nelfinavir saquinavir indinavir or amprenavir For the first week patients will have a daily blood test to determine HIV blood levels Afterwards treatment will continue on an outpatient basis with clinic visits every 4 to 8 weeks for physical exams lab tests and other procedures as required The study will last approximately 48 weeks Patients who benefit from capravirine therapy may be able to continue to receive the drug from the drug company sponsor or as part of another study or the protocol for this study may be amended to lengthen the treatment period
Detailed Description:
This is a pediatric phase I dose escalation study to determine a biologically active dose and to obtain information concerning the safety tolerability and pharmacokinetics of capravirine AG 15495-35-dichlorophenylthio-4-1-methylethyl-1-4-pyridinylmethyl-1H-imidazol-2-methanol carbamate a potent non-nucleoside HIV-1 reverse transcriptase RT inhibitor that induces a novel pattern of resistance mutations In addition to obtaining needed biological activity pediatric safety tolerability and pharmacokinetic data the study will utilize capravirines potent antiretroviral activity and novel resistance mutation pattern together with serial measurements of plasma HIV viral load flow cytometry and genotypic and phenotypic viral resistance analysis to conduct pilot studies in pediatric HIV pathogenesis the response to antiretroviral therapy and to develop strategies to optimize the management of pediatric antiretroviral therapy We will also use initial viral decay dynamics and other patient characteristics to model predictions for the long-term response to antiretroviral therapy We will enroll children who have become refractory to or have experienced toxicity on prior therapy The study will include resistance testing on the failing regimen a one week period off antiretrovirals washout period an initial 6 days of capravirine monotherapy followed by capravirine in combination with the optimal antiretroviral therapy as determined by their baseline viral resistance mutation pattern and history The patients will be followed for at least 48 weeks to assess long-term tolerability and toxicity and to assess the clinical virological and immunological response to capravirine
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 |
|---|---|---|---|
| 01-C-0025 | None | None | None |