Ignite Creation Date:
2024-05-05 @ 5:25 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00458302
Status:
COMPLETED
Last Update Posted:
2012-12-19
First Post:
2007-04-06
Brief Title:
Treatment Simplification by DarunavirRitonavir 800100 mg Once a Day Versus a Triple Combination Therapy With DarunavirRitonavir
Sponsor:
Janssen-Cilag International NV
Organization:
Janssen-Cilag International NV
Study Overview
Official Title:
A Randomised Controlled Open-label Trial to Compare the Efficacy Safety and Tolerability of a Treatment Simplification by DarunavirRitonavir DRVr 800100 mg OD vs a Triple Combination Therapy With DRVr in HIV-1 Infected Patients With Undetectable Plasma HIV-RNA on Their Current Treatments
Status:
COMPLETED
Status Verified Date:
2012-12
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:
MONET
Brief Summary:
The purpose of the study is to compare the efficacy safety and tolerability of darunavirritonavir 800100 mg once a day OD as a monotherapy versus a triple combination therapy containing 2 nucleosides and darunavirritonavir in 250 HIV-1 infected patients who have been on Highly Active Antiretroviral Therapy HAART and have plasma viral load below 50 copiesml for at least 24 weeks
Detailed Description:
This study is randomised patients are assigned different treatments based on chance controlled open-label trial to compare the efficacy safety and tolerability of darunavirritonavir DRVr 800100 mg once a day OD as a monotherapy versus a triple combination therapy containing 2 nucleosides and DRVr in 250 HIV-1 infected patients Patients will be considered eligible if they have not changed any antiretroviral drugs for at least 8 weeks prior to screening and have documented evidence of plasma viral load or plasma HIV-1 RNA 50 copiesmL for at least 24 weeks prior to being screened The trial will consist of a screening period up to 4 weeks a 48-week treatment period followed by a 4-week follow-up FU period The primary objective is to demonstrate non-inferiority in efficacy of DRVr versus the triple combination therapy containing DRVr with respect to confirmed virologic response defined as plasma HIV-1 RNA 50 copiesmL at 48 weeksPatients will be assigned a study medication based on a 11 ratio to either switch to a triple combination therapy containing 2 nucleosides and DRVr 800100 mg OD or initiate monotherapy with DRVr 800100 mg OD Patients in the triple combination arm who are already on 2 nucleosides prior to randomisation may remain on these or switch them at baseline Patients randomised to the monotherapy arm will discontinue Highly Active Antiretroviral Therapy HAART at baseline and commence DRVr 800100 mg OD A Data and Safety Monitoring Board DSMB has been commissioned for this study The role of the DSMB is to review the progress of the trial and the accumulating data to detect evidence of early safety issues for the patients while the trial is ongoing An interim analysis will be performed after 24 weeks of treatment The results of the Week 24 analysis will be used to determine whether long-term follow-up to 72 and 96 weeks will be done The protease inhibitor PI component of the regimen cannot be changed until the end of the treatment period and the nucleoside reverse transcriptase inhibitors NRTIs cannot be modified until the end of the treatment period with the following exception single antiretroviral ARV substitutions will be allowed for tolerabilitytoxicity reasons as long as this can be linked to an adverse event AE or an serious adverse event SAE After withdrawal of the patient from the trial changes in the ARV regimen are allowed after the assessments of the withdrawal visit have been performed
Temporary interruption of all ARVs will be allowed in the event of suspected toxicity as long as the temporary interruption is associated with and can be linked to an AE or a SAE For the control arm the nucleoside analogues could be re-optimized at baseline or on study and all approved ARVs allowed However PIs other than DRVr are not allowed during the treatment period Patients who cannot resume study medication will have to be withdrawn A physical examination will be done at protocol-scheduled visits and vital signs will be monitored at each study visit In addition at each study visit every patient will be asked about the occurrence of or change to AEs since they were last seen by the investigator Laboratory samples for haematology and serum chemistry will be drawn and the results determined and transmitted to the investigator Urinalysis will be performed Pregnancy test will be done at each visit for female participants of child-bearing potential The primary endpoint will be the proportion with virologic response defined as a confirmed plasma HIV-1 RNA 50 copiesmL at Week 48The study hypothesis is that DRVr monotherapy will be as effective as a triple combination regimen and will be well tolerated in this early pre-treated HIV-1 patients Two 400mg tablets of darunavir once daily orally within 30 minutes after completion of a meal for 48 weeks
Temporary interruption of all ARVs will be allowed in the event of suspected toxicity as long as the temporary interruption is associated with and can be linked to an AE or a SAE For the control arm the nucleoside analogues could be re-optimized at baseline or on study and all approved ARVs allowed However PIs other than DRVr are not allowed during the treatment period Patients who cannot resume study medication will have to be withdrawn A physical examination will be done at protocol-scheduled visits and vital signs will be monitored at each study visit In addition at each study visit every patient will be asked about the occurrence of or change to AEs since they were last seen by the investigator Laboratory samples for haematology and serum chemistry will be drawn and the results determined and transmitted to the investigator Urinalysis will be performed Pregnancy test will be done at each visit for female participants of child-bearing potential The primary endpoint will be the proportion with virologic response defined as a confirmed plasma HIV-1 RNA 50 copiesmL at Week 48The study hypothesis is that DRVr monotherapy will be as effective as a triple combination regimen and will be well tolerated in this early pre-treated HIV-1 patients Two 400mg tablets of darunavir once daily orally within 30 minutes after completion of a meal for 48 weeks
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2006-006437-40 | EUDRACT_NUMBER | Janssen-Cilag International NV | None |
| TMC114HIV3006 | OTHER | None | None |