Ignite Creation Date:
2025-12-25 @ 4:04 AM
Ignite Modification Date:
2025-12-26 @ 2:59 AM
Study NCT ID:
NCT01266902
Status:
COMPLETED
Last Update Posted:
2021-03-04
First Post:
2010-12-23
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Trial With TMC278-TIDP6-C222 for Continued TMC278 Access in Patients Infected With Human Immunodeficiency Virus-1
Sponsor:
Janssen R&D Ireland
Organization:
Study Overview
Official Title:
An Open-label Trial With TMC278 25 mg q.d. in Combination With a Background Regimen Containing 2 N(t)RTI's in HIV-1 Infected Subjects Who Participated in TMC278 Clinical Trials and Were Still Benefitting From Treatment With TMC278
Status:
COMPLETED
Status Verified Date:
2021-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
True
If Expanded Access, NCT#:
NCT03847376
Has Expanded Access, NCT# Status:
APPROVED_FOR_MARKETING
Acronym:
None
Brief Summary:
The purpose of the study is to provide continued access to TMC278 in HIV-1 infected patients who were randomized and treated with TMC278 in the Phase IIb or Phase III trials.
Detailed Description:
This is a Phase III, open-label (all people know the identity of the drug), multicenter, roll-over trial to provide continued access to TMC278 to HIV-1 infected patients who were randomized (the study drug is assigned by chance) and treated with TMC278 in the Phase IIb (TMC278-C204 \[C204\]) or Phase III trials (i.e., TMC278-TiDP6-C209 \[C209\] or TMC278-TiDP6-C215 \[C215\]) and who continue to benefit from their antiretroviral treatment, according to the investigator. In addition, information on the long-term safety and tolerability, including resistance data in case of virologic failures, of oral doses of TMC278 25 mg once daily (q.d.) in combination with a background regimen containing 2 N(t)RTIs will be collected. Available efficacy data will also be collected. Approximately 750 HIV-1 infected individuals are expected to participate in this trial. The duration of participation in the study for an individual participant will be 2 to 3 years. The final/withdrawal visit of the Phase IIb or Phase III trials will be the first visit of this trial. Safety and tolerability will be evaluated throughout the trial. Visits and assessments performed should be based on the local, generally accepted standard of care, with visits occurring at least every 6 months. Oral tablets of TMC278 25 mg once daily (q.d.) should be administered together with a meal.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: