A Trial With TMC278-TIDP6-C222 for Continued TMC278 Access in Patients Infected With Human Immunodeficiency Virus-1

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Janssen R&D Ireland
ClinicalTrials.gov Identifier:
NCT01266902
First received: December 23, 2010
Last updated: March 11, 2014
Last verified: March 2014

December 23, 2010
March 11, 2014
February 2011
December 2015   (final data collection date for primary outcome measure)
  • The number of participants affected by an adverse event [ Time Frame: Up to 3 years ] [ Designated as safety issue: Yes ]
  • Any Division of AIDS (DAIDS) grade 3/4 rash [ Time Frame: Up to 3 years ] [ Designated as safety issue: Yes ]
  • Incidence of adverse events (AEs) considered at least possibly related to TMC278, serious AEs, AEs leading to discontinuation [ Time Frame: Up to 3 years ] [ Designated as safety issue: Yes ]
  • Any Division of AIDS (DAIDS) grade 3/4 rash [ Time Frame: Up to 3 years ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01266902 on ClinicalTrials.gov Archive Site
  • HIV RNA levels [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
  • CD4+ cell count [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Trial With TMC278-TIDP6-C222 for Continued TMC278 Access in Patients Infected With Human Immunodeficiency Virus-1
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

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.

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.

Interventional
Phase 3
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
HIV-1 Infection
Drug: Rilpivirine
25 mg once daily
Experimental: Rilpivirine
Rilpivirine 25 mg once daily
Intervention: Drug: Rilpivirine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
488
December 2015
December 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients are HIV-1 infected and were previously randomized to receive TMC278 in a TMC278 clinical trial and completed the protocol-defined treatment period.
  • Patients continue to benefit from treatment with TMC278 in the opinion of the investigator.
  • Patient can comply with the current protocol requirements.
  • The patient's general medical condition, in the investigator's opinion, does not interfere with participation in the trial.

Exclusion Criteria:

  • Use of disallowed concomitant therapy.
  • Females of childbearing potential who are pregnant, or without the use of effective birth control methods, or not willing to continue practicing these birth control methods during the trial and for at least 1 month after the end of the trial (or last intake of TMC278).
  • Non-vasectomized heterosexually active male patients without the use of effective birth control methods or not willing to continue practicing these birth control methods during the trial and for at least 1 month after the end of the trial (or after last intake of TMC278).
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Argentina,   Australia,   Austria,   Belgium,   Canada,   Chile,   China,   Denmark,   France,   Germany,   Netherlands,   Puerto Rico,   Romania,   Russian Federation,   South Africa,   Spain,   Sweden,   Taiwan,   Thailand,   United Kingdom
 
NCT01266902
CR017434, TMC278-TiDP6-C222
No
Janssen R&D Ireland
Janssen R&D Ireland
Not Provided
Study Director: Janssen R&D Ireland Clinical Trial Janssen R&D Ireland
Janssen R&D Ireland
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP