Ignite Creation Date:
2024-05-05 @ 11:28 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00043953
Status:
COMPLETED
Last Update Posted:
2007-09-27
First Post:
2002-08-15
Brief Title:
LopinavirRitonavir in Combination With Saquinavir Mesylate or LamivudineZidovudine to Explore Metabolic Toxicities in Antiretroviral HIV-Infected Subjects
Sponsor:
Abbott
Organization:
Abbott
Study Overview
Official Title:
A Phase II Study of LopinavirRitonavir in Combination With Saquinavir Mesylate or LamivudineZidovudine to Explore Metabolic Toxicities in Antiretroviral HIV-Infected Subjects
Status:
COMPLETED
Status Verified Date:
2007-09
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 objectives of this study are to explore the metabolic toxicities associated with lopinavirritonavir LPVr plus saquinavir mesylate INV versus LPVr plus Combivir in antiretroviral naïve subjects and to assess the overall safety tolerability and efficacy of LPVr plus INV versus LPVr plus Combivir in antiretroviral naïve subjects and to assess the pharmacokinetics of 400 mg INV taken twice a day BID 600 mg INV BID and 800 mg INV BID in combination with 400 mg lopinavir100 mg ritonavir plus 150 mg lamivudine300 mg zidovudine BID
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