Ignite Creation Date:
2024-05-05 @ 4:58 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00355719
Status:
COMPLETED
Last Update Posted:
2019-12-04
First Post:
2006-07-24
Brief Title:
Study to Evaluate the Influence of Nevirapine to Atazanavir in Steady State Equilibrium in HIV Patients
Sponsor:
Germans Trias i Pujol Hospital
Organization:
Germans Trias i Pujol Hospital
Study Overview
Official Title:
Clinical Pilot Trial to Evaluate the Influence of Nevirapine in Exposure to Atazanavir in Steady State Equilibrium in HIV-infected Adult Patients
Status:
COMPLETED
Status Verified Date:
2019-12
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:
The purpose of this study is to evaluate the influence of nevirapine in exposure to atazanavir boosted with ritonavir in steady state equilibrium in HIV-infected adult patients
Detailed Description:
In recent years new treatment strategies have appeared aimed at reducing the risk of treatment-derived toxicity without compromising efficacy
Of the recent antiretroviral drugs atazanavir is a protease inhibitor PI whose pharmacokinetic profile allows it to be given in a single daily take with a scant impact on lipid metabolism This second characteristic makes atazanavir a good alternative for patients with a high vascular risk However one of its drawbacks is that it may present clinically relevant interactions with other drugs
Another antiretroviral agent with a scant impact on lipid metabolism is nevirapine Different studies have described an improvement in lipid profile as well as a less atherogenic tendency in patients treated with nevirapine Moreover the combination of nevirapine with PI drugs in the context of nucleoside-sparing strategies may permit a suitable control of viral replication and an improvement in the mitochondrial toxicity derived from treatment with NTRI which may possibly result in a minor incidence or in a clinical improvement of lipodystrophy
The combination of atazanavir with nevirapine may be of major interest in HIV-infected patients that have had a cardiovascular event secondary prevention or are at a high risk of having one primary prevention Similarly this combination of drugs may be promising as a nucleoside-sparing strategy However according to preliminary data the joint administration of nevirapine with atazanavir may lead to a reduction in the atazanavir plasma concentration Thus before evaluating the clinical utility of this combination of drugs pharmacokinetic studies evaluating the existence of significant pharmacokinetic interactions between both are necessary
Of the recent antiretroviral drugs atazanavir is a protease inhibitor PI whose pharmacokinetic profile allows it to be given in a single daily take with a scant impact on lipid metabolism This second characteristic makes atazanavir a good alternative for patients with a high vascular risk However one of its drawbacks is that it may present clinically relevant interactions with other drugs
Another antiretroviral agent with a scant impact on lipid metabolism is nevirapine Different studies have described an improvement in lipid profile as well as a less atherogenic tendency in patients treated with nevirapine Moreover the combination of nevirapine with PI drugs in the context of nucleoside-sparing strategies may permit a suitable control of viral replication and an improvement in the mitochondrial toxicity derived from treatment with NTRI which may possibly result in a minor incidence or in a clinical improvement of lipodystrophy
The combination of atazanavir with nevirapine may be of major interest in HIV-infected patients that have had a cardiovascular event secondary prevention or are at a high risk of having one primary prevention Similarly this combination of drugs may be promising as a nucleoside-sparing strategy However according to preliminary data the joint administration of nevirapine with atazanavir may lead to a reduction in the atazanavir plasma concentration Thus before evaluating the clinical utility of this combination of drugs pharmacokinetic studies evaluating the existence of significant pharmacokinetic interactions between both are necessary
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 |
|---|---|---|---|
| 2006-001140-31 | None | None | None |