Ignite Creation Date:
2024-05-05 @ 11:46 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00122590
Status:
TERMINATED
Last Update Posted:
2005-08-01
First Post:
2005-07-20
Brief Title:
Evaluation of Therapeutic Drug Monitoring of Protease Inhibitors on Virologic Success and Tolerance of Highly Active Antiretroviral Therapy HAART
Sponsor:
French National Agency for Research on AIDS and Viral Hepatitis
Organization:
French National Agency for Research on AIDS and Viral Hepatitis
Study Overview
Official Title:
Prospective Trial to Evaluate How Therapeutic Drug Monitoring of Protease Inhibitors Increases Virologic Success and Tolerance of HAART ANRS 111 COPHAR2
Status:
TERMINATED
Status Verified Date:
2005-07
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:
This Cophar2 study is a trial which evaluates repeated early therapeutic drug monitoring from weeks 2 to 24 after the initiation of HAART including either indinavirr lopinavirr or the new 625 mg formulation of nelfinavir twice-a-day bid If trough concentrations were out of the range given for each protease inhibitor PI the PI dose was adjusted
Detailed Description:
Because of the large pharmacokinetic inter-patient variability of protease inhibitors PI therapeutic drug monitoring TDM of protease inhibitor PI has been proposed to improve efficacy and tolerance of PI-containing HAART The objective of the Cophar2 trial is to evaluate the feasibility and the impact of an early therapeutic drug monitoring in PI-naive HIV-1 infected patients in order to warrant virological success and safety of HAART
It is a prospective open multicenter trial with repeated early TDM weeks 2 8 or 16 24 after the initiation of HAART including either indinavirr IDV lopinavirr LPV or the new 625 mg formulation of nelfinavir NFV bid It was planned to include 99 PI-naïve HIV-1 infected patients over 18 years old 33 for each PI Concentrations were measured by HPLC in each center If trough concentrations were out of the range of 150-500 2500-7000 or 1500-5500 ngml for IDV LPV and NFV respectively the PI doses were adjusted possibly more than once during the first 24 weeks of follow-up Adjustments were done by steps of one pill 200 13333 or 250 mg for IDV LPVr or NFV respectively bid Failure of the strategy was defined by either two consecutive viral loads over 200 copiesml between weeks 16 and 48 or a validated PI-related adverse event grade III or IV or a grade II diarrhoea or renal lithiasis Patients without adverse events before week 16 were defined as assessable if they had at least the virological assessment of week 16
It is a prospective open multicenter trial with repeated early TDM weeks 2 8 or 16 24 after the initiation of HAART including either indinavirr IDV lopinavirr LPV or the new 625 mg formulation of nelfinavir NFV bid It was planned to include 99 PI-naïve HIV-1 infected patients over 18 years old 33 for each PI Concentrations were measured by HPLC in each center If trough concentrations were out of the range of 150-500 2500-7000 or 1500-5500 ngml for IDV LPV and NFV respectively the PI doses were adjusted possibly more than once during the first 24 weeks of follow-up Adjustments were done by steps of one pill 200 13333 or 250 mg for IDV LPVr or NFV respectively bid Failure of the strategy was defined by either two consecutive viral loads over 200 copiesml between weeks 16 and 48 or a validated PI-related adverse event grade III or IV or a grade II diarrhoea or renal lithiasis Patients without adverse events before week 16 were defined as assessable if they had at least the virological assessment of week 16
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