Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001443
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
1999-11-03
Brief Title:
A Phase I II Study of the Protease Inhibitor Indinavir MK-0639 in Children With HIV Infection
Sponsor:
National Cancer Institute NCI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
A Phase I II Study of the Protease Inhibitor Indinavir MK-0639 in Children With HIV Infection
Status:
COMPLETED
Status Verified Date:
2000-03
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 is a phase III study to determine the safety and tolerance of the protease inhibitor indinavir MK-0639 alone and then in combination with HIV reverse transcriptase inhibitor therapy in children with HIV infection Indinavir sulfate the capsule formulation has been shown to have potent antiviral activity and an acceptable safety profile in adults HIV-infected children who have not received prior antiretroviral therapy and children who have become refractory to prior therapy or who have experienced toxicity to prior therapy will be included In addition we will explore viral and CD4 cell kinetics before starting therapy and following exposure to antiretroviral agents
The study will be conducted in three parts
1 In order to help interpret the antiviral activity of indinavir the virologic and immunologic profile of children will be studied within 2 weeks prior to starting the therapeutic part For children who have never been treated this will be before the initiation of any antiretroviral therapy and for children who have already received antiretroviral therapy this will be done during the initial wash-out phase that is routinely interposed between two different treatment regimens
2 The initial 16 weeks of therapy will then evaluate the toxicities pharmacokinetics and preliminary efficacy of single drug therapy with indinavir
3 Subsequently all children who are able to tolerate the combination of zidovudine and lamivudine ie have no prior history of intolerance to one of these two agents will be treated with these two reverse transcriptase inhibitors in addition to the protease inhibitor indinavir Zidovudine and lamivudine will be added after 16 weeks at a fixed dosage Toxicity pharmacokinetics and preliminary efficacy of indinavir will also be investigated after combination therapy All patients who wish to remain in this study after 96 weeks of therapy and who do not meet off study criteria will be permitted to receive extended treatment with their current indinavir combination therapy for an additional 48 weeks
The study will determine the pharmacokinetic profile of indinavir given as single drug or in combination with zidovudine and lamivudine It will assess the preliminary antiviral and clinical activity by monitoring clinical status viral burden in plasma and markers of immunologic status Based on safety and preliminary efficacy results from studies performed in adults we will study three dose levels which are expected to result in drug levels above the IC95 of HIV-1 for all or most of the dosing interval
The study will be conducted in three parts
1 In order to help interpret the antiviral activity of indinavir the virologic and immunologic profile of children will be studied within 2 weeks prior to starting the therapeutic part For children who have never been treated this will be before the initiation of any antiretroviral therapy and for children who have already received antiretroviral therapy this will be done during the initial wash-out phase that is routinely interposed between two different treatment regimens
2 The initial 16 weeks of therapy will then evaluate the toxicities pharmacokinetics and preliminary efficacy of single drug therapy with indinavir
3 Subsequently all children who are able to tolerate the combination of zidovudine and lamivudine ie have no prior history of intolerance to one of these two agents will be treated with these two reverse transcriptase inhibitors in addition to the protease inhibitor indinavir Zidovudine and lamivudine will be added after 16 weeks at a fixed dosage Toxicity pharmacokinetics and preliminary efficacy of indinavir will also be investigated after combination therapy All patients who wish to remain in this study after 96 weeks of therapy and who do not meet off study criteria will be permitted to receive extended treatment with their current indinavir combination therapy for an additional 48 weeks
The study will determine the pharmacokinetic profile of indinavir given as single drug or in combination with zidovudine and lamivudine It will assess the preliminary antiviral and clinical activity by monitoring clinical status viral burden in plasma and markers of immunologic status Based on safety and preliminary efficacy results from studies performed in adults we will study three dose levels which are expected to result in drug levels above the IC95 of HIV-1 for all or most of the dosing interval
Detailed Description:
This is a phase III study to determine the safety and tolerance of the protease inhibitor indinavir MK-0639 alone and then in combination with HIV reverse transcriptase inhibitor therapy in children with HIV infection Indinavir sulfate the capsule formulation has been shown to have potent antiviral activity and an acceptable safety profile in adults HIV-infected children who have not received prior antiretroviral therapy and children who have become refractory to prior therapy or who have experienced toxicity to prior therapy will be included In addition we will explore viral and CD4 cell kinetics before starting therapy and following exposure to antiretroviral agents
The study will be conducted in three parts
1 In order to help interpret the antiviral activity of indinavir the virologic and immunologic profile of children will be studied within 2 weeks prior to starting the therapeutic part For children who have never been treated this will be before the initiation of any antiretroviral therapy and for children who have already received antiretroviral therapy this will be done during the initial wash-out phase that is routinely interposed between two different treatment regimens
2 The initial 16 weeks of therapy will then evaluate the toxicities pharmacokinetics and preliminary efficacy of single drug therapy with indinavir
3 Subsequently all children who are able to tolerate the combination of zidovudine and lamivudine ie have no prior history of intolerance to one of these two agents will be treated with these two reverse transcriptase inhibitors in addition to the protease inhibitor indinavir Zidovudine and lamivudine will be added after 16 weeks at a fixed dosage Toxicity pharmacokinetics and preliminary efficacy of indinavir will also be investigated after combination therapy All patients who wish to remain in this study after 96 weeks of therapy and who do not meet off study criteria will be permitted to receive extended treatment with their current indinavir combination therapy for an additional 48 weeks The study will determine the pharmacokinetic profile of indinavir given as single drug or in combination with zidovudine and lamivudine It will assess the preliminary antiviral and clinical activity by monitoring clinical status viral burden in plasma and markers of immunologic status Based on safety and preliminary efficacy results from studies performed in adults we will study three dose levels which are expected to result in drug levels above the IC95 of HIV-1 for all or most of the dosing interval
The study will be conducted in three parts
1 In order to help interpret the antiviral activity of indinavir the virologic and immunologic profile of children will be studied within 2 weeks prior to starting the therapeutic part For children who have never been treated this will be before the initiation of any antiretroviral therapy and for children who have already received antiretroviral therapy this will be done during the initial wash-out phase that is routinely interposed between two different treatment regimens
2 The initial 16 weeks of therapy will then evaluate the toxicities pharmacokinetics and preliminary efficacy of single drug therapy with indinavir
3 Subsequently all children who are able to tolerate the combination of zidovudine and lamivudine ie have no prior history of intolerance to one of these two agents will be treated with these two reverse transcriptase inhibitors in addition to the protease inhibitor indinavir Zidovudine and lamivudine will be added after 16 weeks at a fixed dosage Toxicity pharmacokinetics and preliminary efficacy of indinavir will also be investigated after combination therapy All patients who wish to remain in this study after 96 weeks of therapy and who do not meet off study criteria will be permitted to receive extended treatment with their current indinavir combination therapy for an additional 48 weeks The study will determine the pharmacokinetic profile of indinavir given as single drug or in combination with zidovudine and lamivudine It will assess the preliminary antiviral and clinical activity by monitoring clinical status viral burden in plasma and markers of immunologic status Based on safety and preliminary efficacy results from studies performed in adults we will study three dose levels which are expected to result in drug levels above the IC95 of HIV-1 for all or most of the dosing interval
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 |
|---|---|---|---|
| 95-C-0163 | None | None | None |