Ignite Creation Date:
2024-05-05 @ 7:40 PM
Last Modification Date:
2024-10-26 @ 9:52 AM
Study NCT ID:
NCT00718536
Status:
COMPLETED
Last Update Posted:
2019-12-05
First Post:
2008-07-16
Brief Title:
Clinical Trial Assessing Once Daily Raltegravir Administration 800 mg QD in HIV-1-Infected Patients Receiving Unboosted Atazanavir 400 mg QD- Based Antiretroviral Therapy
Sponsor:
Germans Trias i Pujol Hospital
Organization:
Germans Trias i Pujol Hospital
Study Overview
Official Title:
Clinical Trial Assessing Once Daily Raltegravir Administration 800 mg QD in HIV-1-Infected Patients Receiving Unboosted Atazanavir 400 mg QD- Based Antiretroviral Therapy
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 co-administration of raltegravir with medicinal products that are knouwn to be potent UGT1A1 inhibitors such as atazanavir may increase plasma levels of raltegravir So once daily raltegravir 800 mg QD instead of twice a day 400 mg BID could be an appropriate therapeutic option in HIV-infected patients also receiving atazanavir-containing antiretroviral regimens In this study pharmacokinetic data supporting this hypothesis are recovered
Detailed Description:
Treatment adherence is crucial for the effectiveness of antiretroviral therapy and in an attempt to promote treatment adherence by the patients once daily QD regimens are preferred rather than twice daily BID regimens
The dose of 400 mg BID of raltegravir has been recently licensed for the treatment of human immunodeficiency virus HIV-1 infection in treatment-experienced adult patients
Raltegravir is eliminated mainly by metabolism via uridine diphosphate glucuronyl transferase UGT1A1-mediated glucuronidation pathway Thus co-administration of raltegravir with medicinal products that are known to be potent UGT1A1 inhibitors such as atazanavir may increase plasma levels of raltegravir
Based on these data it could be hypothesized that once daily raltegravir 800 mg QD could be an appropriate therapeutic option in HIV-infected patients also receiving atazanavir-containing antiretroviral regimens However pharmacokinetic data supporting this hypothesis are lacking
The dose of 400 mg BID of raltegravir has been recently licensed for the treatment of human immunodeficiency virus HIV-1 infection in treatment-experienced adult patients
Raltegravir is eliminated mainly by metabolism via uridine diphosphate glucuronyl transferase UGT1A1-mediated glucuronidation pathway Thus co-administration of raltegravir with medicinal products that are known to be potent UGT1A1 inhibitors such as atazanavir may increase plasma levels of raltegravir
Based on these data it could be hypothesized that once daily raltegravir 800 mg QD could be an appropriate therapeutic option in HIV-infected patients also receiving atazanavir-containing antiretroviral regimens However pharmacokinetic data supporting this hypothesis are lacking
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