Ignite Creation Date:
2024-05-05 @ 5:18 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00421473
Status:
COMPLETED
Last Update Posted:
2020-11-12
First Post:
2007-01-11
Brief Title:
Drug Interaction Study Between Atovaquone and Antiretroviral Agents in HIV-1 Infected Patients
Sponsor:
Radboud University Medical Center
Organization:
Radboud University Medical Center
Study Overview
Official Title:
Drug Interactions Between ATOvaquone Used in MAlaria Prophylaxis and Antiretroviral Agents in HIV-1 Infected Patients ATOMA
Status:
COMPLETED
Status Verified Date:
2020-11
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:
Malarone atovaquoneproguanil is frequently used in malaria prophylaxis Unfortunately there are indications that certain anti-HIV agents may decrease atovaquone plasma levels by induction of atovaquone metabolism
For travelling HIV patients the clinical consequences of these possible drug drug interactions are serious since a diminished exposure to the anti-malarial drug will result in suboptimal prophylaxis of malaria and potential development of drug resistant strains of Plasmodium falciparum
The purpose of this study is to find out if HIV patients using HAART regimes with either lopinavirritonavir atazanavirritonavir or efavirenz have lower atovaquone plasma levels than healthy volunteers after a single dose of atovaquoneproguanil
For travelling HIV patients the clinical consequences of these possible drug drug interactions are serious since a diminished exposure to the anti-malarial drug will result in suboptimal prophylaxis of malaria and potential development of drug resistant strains of Plasmodium falciparum
The purpose of this study is to find out if HIV patients using HAART regimes with either lopinavirritonavir atazanavirritonavir or efavirenz have lower atovaquone plasma levels than healthy volunteers after a single dose of atovaquoneproguanil
Detailed Description:
None
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