Ignite Creation Date:
2024-05-05 @ 6:38 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00513513
Status:
TERMINATED
Last Update Posted:
2010-04-26
First Post:
2007-08-06
Brief Title:
TMC114-C227 A Study to Evaluate the Effectiveness and Safety of TMC114 Darunavir With a Low Dose of Ritonavir as Monotherapy no Other Anti-HIV Drugs Will be Given in Patients Who Have Never Been Treated With Antiretrovirals Anti-HIV Drugs Previously
Sponsor:
Tibotec Pharmaceuticals Ireland
Organization:
Tibotec Pharmaceuticals Ireland
Study Overview
Official Title:
A Phase II Open Label Trial in Treatment nave HIV 1 Infected Subjects Who Will Receive TMC114Rtv as a Monotherapy
Status:
TERMINATED
Status Verified Date:
2010-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Poor recruitment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is an open label study no placebos are used all patients will receive the true medication to evaluate the effectiveness of TMC114rtv in treatment naÃ-ve never previously received anti-HIV drugs HIV 1 infected patients
Detailed Description:
This is an open label no placebo uncontrolled all patients will receive TMC114 with ritonavir at the same dose trial to investigate the sustained anti-viral activity of TMC114rtv monotherapy in 24 treatment naïve HIV 1 infected patients over a period of 48 weeksTMC114 800 mg daily 2 tablets of 400 mg F021 will be given together with 1 capsule 100 mg of ritonavirInitially 11 subjects Panel A screening viral load between 10000 and 100000 copiesmL will be included and followed for 8 weeks If after 8 weeks of dosing at least 7 subjects virologically respond viral load 400 copiesmL 13 additional patients Panel B will be included If no virologic failure is observed in at least 18 out of 24 patients who complete 8 weeks of dosing the trial will continue as planned In case more than 6 patients in Panel A and Panel B develop a virologic failure after 8 weeks of treatment the trial will be stopped to conclude the treatment is not effectiveThe 13 additional patients enrolled in Panel B should have a screening viral load between 20000 and 500000 copiesmL The CD4 cell count in all 24 patients should be 100 cellsµL at screening The patients medical condition adverse events side effects study medication compliance and laboratory evaluations for effectiveness and safety will be assessed at regular intervals At the end of the 48 weeks treatment period patients will be followed for an additional 4 weeks to evaluate any side effects or laboratory abnormalities Treatment with TMC114rtv will be extended for all patients who continue to benefit after 48 weeks 2 oral tablets of TMC114 400 mg will be administered once daily with 1 capsule 100mg of ritonavir 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