A Trial With TMC278-TIDP6-C222 for Continued TMC278 Access in Patients Infected With Human Immunodeficiency Virus-1
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|ClinicalTrials.gov Identifier: NCT01266902|
Recruitment Status : Completed
First Posted : December 24, 2010
Results First Posted : March 4, 2021
Last Update Posted : March 4, 2021
|Condition or disease||Intervention/treatment||Phase|
|HIV-1 Infection||Drug: Rilpivirine||Phase 3|
Expanded Access : An investigational treatment associated with this study has been approved for sale to the public. More info ...
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||482 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||February 2011|
|Actual Primary Completion Date :||February 2020|
|Actual Study Completion Date :||February 2020|
Rilpivirine 25 mg once daily
25 mg once daily
- Number of Participants With Adverse Events (AEs) [ Time Frame: Up to 7 years ]An AE can be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non investigational) product, whether or not related to that medicinal (investigational or non investigational) product.
- Number of Participants With Grade 3/4 Events of Rash Irrespective of Causality [ Time Frame: Up to 7 years ]Number of participants with grade 3/4 events of rash irrespective of causality were assessed. A grade 3 rash defined as diffuse macular, maculopapular or morbilliform rash with vesicles or limited number of bullae or; rash with superficial ulcerations of mucous membranes limited to 1 anatomical site or; rash with at least one of the following: elevations in aspartate aminotransferase (AST)/alanine aminotransferase (ALT) more than 2*baseline value and at least 5 times upper limit of normal; fever greater than (>) 38 degree celsius or 100 degree fahrenheit; eosinophils > 1000/millimeter (mm)^3; serum sickness-like reaction. A grade 4 rash defined as the following: extensive or generalized bullous lesions or; Stevens-Johnsons Syndrome (SJS) or ulceration of mucous membrane involving 2 or more distinct mucosal sites or toxic epidermal necrolysis.
- Time to Virologic Rebound [ Time Frame: Up to Week 360 ]Time to virologic rebound was time to (first) human immunodeficiency virus type1 (HIV-1) ribonucleic acid (RNA) greater than or equal to (>=) 50 or >=200 copies/milliliter (copies/mL). The mean survival time and its standard error were underestimated because the largest observation was censored and the estimation was restricted to the largest event time.
- Time To Treatment Failure [ Time Frame: Up to Week 360 ]Time to treatment failure was defined as time to virologic rebound (time to first HIV-1 RNA >= 50 or >= 200 copies/mL) or discontinuation for reason other than RPV having become commercially available in the participating country, whichever came first, calculated as the time (in days) from baseline until treatment failure. The mean survival time and its standard error were underestimated because the largest observation was censored and the estimation was restricted to the largest event time.
- Change From Baseline in Cluster of Differentiation 4 (CD4+) Cell Count for Observed Case Approach Until Week 336 [ Time Frame: Baseline up to weeks 96, 192, 288, 336 ]The immunologic assessment was determined by change from baseline in CD4+ cell count for observed case approach.
- Change From Baseline in CD4+ Cell Count for Non-Completer Equals Failure (NC=F) Approach Until Week 336 [ Time Frame: Baseline up to weeks 96, 192, 288, 336 ]Change from baseline in CD4+ cell count were reported for NC=F approach (participants who discontinued because RPV became commercially available or could be accessed through another source or because the participants switched to other local [RPV-based] treatment options or local standard of care, were censored at that time; other participants after discontinuation had their CD4+ values imputed with baseline value. Intermittently missing values were imputed with a last observation carried-forward approach).
- Number of Participants With Serious Adverse Events (SAEs) [ Time Frame: Up to 7 years ]A SAE is any untoward medical occurrence that at any dose: results in death; is life threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect.
- Number of Participants With AEs Related to Rilpivirine (RPV) [ Time Frame: Up to 7 years ]Number of participants with AEs related to RPV were assessed. An AE can be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non investigational) product, whether or not related to that medicinal (investigational or non investigational) product.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01266902
|Study Director:||Janssen R&D Ireland Clinical Trial||Janssen R&D Ireland|