Ignite Creation Date:
2024-05-05 @ 5:14 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00411996
Status:
COMPLETED
Last Update Posted:
2020-07-17
First Post:
2006-12-14
Brief Title:
The Pharmacokinetics and Safety of IDVr With NRTIs in HIVTB Co-infected Patients Receiving Rifampicin
Sponsor:
The HIV Netherlands Australia Thailand Research Collaboration
Organization:
The HIV Netherlands Australia Thailand Research Collaboration
Study Overview
Official Title:
The Pharmacokinetics and Safety of Ritonavir-boosted Indinavir 600100mg Bid Combined With NRTIs in ARV naïve HIVTB Co-infected Patients Receiving Rifampicin Containing Anti-tuberculosis Therapy
Status:
COMPLETED
Status Verified Date:
2020-07
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:
We believe that there is a strong rationale for the study of IDVr 600100 bid as a boosted-PI combination that in the presence of RMP is able to produce a satisfactory PK profile associated with adequate antiretroviral potency tolerability and efficacy
Detailed Description:
The fixed-dose combination of d4T3TCNVP GPOvir has been widely used in Thailand since June 2002 The prevalence of NNRTI resistance has increased since 2005 Efavirenz-based antiretroviral therapy ART is preferred in patients with TBHIV receiving rifampin-containing TB regimens However efavirenz cannot be used in the context of NNRTI failure intolerance or toxicity The optimal ART in populations receiving rifampicin remains unknown Rifabutin which is recommended in combination with a boosted protease inhibitor PIr is expensive and not available in Thailand and other developing countries Ritonavir-boosted indinavir IDVr is potent and the cheapest boosted PI available in Thailand If IDVr in combination with rifampin demonstrates suitable pharmacokinetics and is well tolerated this regimen might prove useful and could be widely implemented However high rates of gastrointestinal and renal toxicity have been demonstrated in Thai patients receiving standard doses of IDVr 800100 BID We believe that there is a strong rationale to study if IDVr 600100 BID in combination with rifampin is able to produce a satisfactory pharmacokinetic profile with antiretroviral potency tolerability and efficacy
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