Ignite Creation Date:
2024-05-05 @ 5:28 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00460746
Status:
COMPLETED
Last Update Posted:
2013-07-31
First Post:
2007-04-13
Brief Title:
EnfuvirtideCurrent Protease Inhibitor Switch to PREZISTA DarunavirRitonavir TMC125 in HIV Patients With Enfuvirtide Side Effects
Sponsor:
Tibotec Inc
Organization:
Tibotec Inc
Study Overview
Official Title:
Open Label Phase 3b 48 wk Pilot Study of the Antiviral Efficacy and Tolerability of Combination of PREZISTAr and TMC125 When Substituted for Enfuvirtide Current Protease Inhibitors and NNRTIs in Antiretroviral Resistant Patients With Viral Suppression But Who Are Intolerant of Enfuvirtide
Status:
COMPLETED
Status Verified Date:
2013-07
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:
The purpose of this study is to examine the safety tolerability and effectiveness of darunavirritonavir combined with TMC125 when current protease inhibitors Non-Nucleoside Reverse Transcriptase Inhibitors NNRTIs and enfuvirtide are replaced by darunavirritonavir and TMC125 in HIV positive patients who can no longer tolerate enfuvirtide and are experiencing viral suppression Other antiviral drugs in the regimen are to remain unchanged
Detailed Description:
This is a multi-center open-label doctors and patients know which drug is being given Phase IIIb clinical trial to evaluate the effectiveness safety and tolerability of the combination of PREZISTA darunavirritonavir and TMC125 when substituted for enfuvirtide current protease inhibitors and Non-Nucleoside Reverse Transcriptase Inhibitors NNRTIs in antiretroviral resistant patients with viral suppression but who are intolerant of enfuvirtide This study will be conducted in the US at up to 5 sites where 40 patients will receive PREZISTA darunavir ritonavir twice daily 600100mg and TMC125 200 mg twice daily over a 48-week treatment period
The study will consist of a total of 11 patient visits At the screening visit Week -1 to -6 blood will be collected from patients to determine eligibility Once all data are available to determine the eligibility of the patient the baseline visit will be scheduled and trial treatment initiated at this visit The Baseline Visit Day 1 will be followed by a 48-week treatment period The patient will be evaluated at Weeks 2 4 8 12 16 24 36 and 48 Patients will be asked to return for a 2-week follow up visit at Week 50
Treatment will include PREZISTA darunavir ritonavir and TMC125 plus continued nucleosides The patient must continue all existing nucleosides in their background regimen for the duration of the study
During the treatment period the patient will be seen at regular visits during which the investigator will assess the patients medical condition any Adverse Events and study drug compliance Laboratory evaluations for efficacy and safety will be done at regular visits Study patients will receive oral by mouth PREZISTA darunavir 600 mg and 100 mg of ritonavir twice a day in combination with TMC125 200mg orally twice a day for 48 weeks
The study will consist of a total of 11 patient visits At the screening visit Week -1 to -6 blood will be collected from patients to determine eligibility Once all data are available to determine the eligibility of the patient the baseline visit will be scheduled and trial treatment initiated at this visit The Baseline Visit Day 1 will be followed by a 48-week treatment period The patient will be evaluated at Weeks 2 4 8 12 16 24 36 and 48 Patients will be asked to return for a 2-week follow up visit at Week 50
Treatment will include PREZISTA darunavir ritonavir and TMC125 plus continued nucleosides The patient must continue all existing nucleosides in their background regimen for the duration of the study
During the treatment period the patient will be seen at regular visits during which the investigator will assess the patients medical condition any Adverse Events and study drug compliance Laboratory evaluations for efficacy and safety will be done at regular visits Study patients will receive oral by mouth PREZISTA darunavir 600 mg and 100 mg of ritonavir twice a day in combination with TMC125 200mg orally twice a day 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 |
|---|---|---|---|
| TMC114HIV3009 | OTHER | Tibotec Inc | None |