HIV-1 Infection
Conditions
Keywords
HIV-1 Infection, HIV-1, HIV, TMC278-TiDP6-C222, TMC278-C222, TMC278, Rilpivirine
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.
Interventions
DRUGRilpivirine
25 mg once daily
Sponsors
Janssen R&D Ireland
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Events (AEs) | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Cluster of Differentiation 4 (CD4+) Cell Count for Observed Case Approach Until Week 336 | 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 | 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). |
| Time to Virologic Rebound | 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. |
| Number of Participants With AEs Related to Rilpivirine (RPV) | 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. |
| Number of Participants With Serious Adverse Events (SAEs) | 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. |
| Time To Treatment Failure | 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. |
Countries
Argentina, Australia, Austria, Belgium, Canada, Chile, China, Denmark, France, Germany, Netherlands, Puerto Rico, Romania, Russia, South Africa, Spain, Sweden, Taiwan, Thailand, United Kingdom, United States
Participant flow
Pre-assignment details
Total of 482 participants were treated and 437 discontinued at data cut-off date (8 February 2018) because they switched to commercially available rilpivirine (RPV) (371 participants), as planned per protocol. Only 6 of the 482 participants discontinued as they reached a virologic endpoint. At last contact date of last participant under Protocol Amendment 3 (28 February 2020), out of 45 participants 37 switched to commercially available RPV and 6 were lost to follow-up.
Participants by arm
| Arm | Count |
|---|---|
| Rilpivirine (RPV) (TMC278-C204 [C204]) Participants who rolled over from trial C204 (NCT00110305) continued to receive RPV 25 milligrams (mg) once daily (qd) in combination with an investigator-selected background regimen consisting of 2 nucleos(t)ide reverse transcriptase inhibitors (N\[t\]RTI)s starting Day 1. | 119 |
| RPV (TMC278-TiDP6-C209 [C209] and TMC278-TiDP6-C215 [C215]) Participants who rolled over from trial C209 (NCT00540449) and C215 (NCT00543725) continued to receive RPV 25 mg qd in combination with an investigator-selected background regimen consisting of 2 N(t)RTIs starting Day 1. In trial C209, the background regimen was fixed to tenofovir disoproxil fumarate (TDF)/emtricitabine (FTC) and in trial C215, the background regimen was selected by the investigator and contained either abacavir (ABC)/lamivudine (3TC), zidovudine (AZT)/3TC, or TDF/FTC. | 363 |
| Total | 482 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Period 1 (Main Study) | Adverse Event | 3 | 11 | 0 |
| Period 1 (Main Study) | Continued RPV treatment | 11 | 34 | 0 |
| Period 1 (Main Study) | Investigator's decision/Participant's decision | 2 | 3 | 0 |
| Period 1 (Main Study) | Lack of Efficacy | 4 | 2 | 0 |
| Period 1 (Main Study) | Lost to Follow-up | 5 | 12 | 0 |
| Period 1 (Main Study) | Subject non-compliant | 3 | 7 | 0 |
| Period 1 (Main Study) | Withdrawal by Subject | 2 | 12 | 0 |
| Period 2 (After Protocol Amendment 3) | Adverse Event | 0 | 0 | 1 |
| Period 2 (After Protocol Amendment 3) | Lost to Follow-up | 0 | 0 | 6 |
| Period 2 (After Protocol Amendment 3) | Withdrawal by Subject | 0 | 0 | 1 |
Baseline characteristics
| Characteristic | RPV (TMC278-TiDP6-C209 [C209] and TMC278-TiDP6-C215 [C215]) | Total | Rilpivirine (RPV) (TMC278-C204 [C204]) |
|---|---|---|---|
| Age, Continuous | 39.9 years STANDARD_DEVIATION 9.09 | 40.4 years STANDARD_DEVIATION 8.91 | 42 years STANDARD_DEVIATION 8.18 |
| Race/Ethnicity, Customized American Indian or Alaska Native | 4 participants | 4 participants | 0 participants |
| Race/Ethnicity, Customized Asian | 58 participants | 101 participants | 43 participants |
| Race/Ethnicity, Customized Black or African American | 64 participants | 81 participants | 17 participants |
| Race/Ethnicity, Customized Other | 0 participants | 9 participants | 9 participants |
| Race/Ethnicity, Customized White | 237 participants | 287 participants | 50 participants |
| Region of Enrollment ARGENTINA | 16 participants | 35 participants | 19 participants |
| Region of Enrollment AUSTRALIA | 11 participants | 11 participants | 0 participants |
| Region of Enrollment AUSTRIA | 6 participants | 8 participants | 2 participants |
| Region of Enrollment BELGIUM | 13 participants | 13 participants | 0 participants |
| Region of Enrollment CANADA | 21 participants | 21 participants | 0 participants |
| Region of Enrollment CHILE | 12 participants | 12 participants | 0 participants |
| Region of Enrollment CHINA | 18 participants | 26 participants | 8 participants |
| Region of Enrollment DENMARK | 5 participants | 5 participants | 0 participants |
| Region of Enrollment FRANCE | 15 participants | 20 participants | 5 participants |
| Region of Enrollment GERMANY | 24 participants | 27 participants | 3 participants |
| Region of Enrollment ITALY | 10 participants | 10 participants | 0 participants |
| Region of Enrollment NETHERLANDS | 3 participants | 3 participants | 0 participants |
| Region of Enrollment PUERTO RICO | 0 participants | 7 participants | 7 participants |
| Region of Enrollment ROMANIA | 4 participants | 4 participants | 0 participants |
| Region of Enrollment RUSSIAN FEDERATION | 27 participants | 38 participants | 11 participants |
| Region of Enrollment SOUTH AFRICA | 35 participants | 48 participants | 13 participants |
| Region of Enrollment SPAIN | 14 participants | 14 participants | 0 participants |
| Region of Enrollment SWEDEN | 3 participants | 3 participants | 0 participants |
| Region of Enrollment TAIWAN | 2 participants | 2 participants | 0 participants |
| Region of Enrollment THAILAND | 31 participants | 65 participants | 34 participants |
| Region of Enrollment UNITED KINGDOM | 17 participants | 25 participants | 8 participants |
| Region of Enrollment UNITED STATES | 76 participants | 85 participants | 9 participants |
| Sex: Female, Male Female | 84 Participants | 125 Participants | 41 Participants |
| Sex: Female, Male Male | 279 Participants | 357 Participants | 78 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 119 | 2 / 363 |
| other Total, other adverse events | 25 / 119 | 61 / 363 |
| serious Total, serious adverse events | 9 / 119 | 16 / 363 |
Outcome results
Primary
Number of Participants With Adverse Events (AEs)
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.
Time frame: Up to 7 years
Population: The intent-to-treat (ITT) population included all participants who have taken at least 1 dose of rilpivirine (RPV), regardless of their compliance with the protocol and adherence to the dosing regimens.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Rilpivirine (RPV) (TMC278-C204 [C204]) | Number of Participants With Adverse Events (AEs) | 32 Participants |
| RPV (TMC278-TiDP6-C209 [C209] and TMC278-TiDP6-C215 [C215]) | Number of Participants With Adverse Events (AEs) | 70 Participants |
Primary
Number of Participants With Grade 3/4 Events of Rash Irrespective of Causality
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 frame: Up to 7 years
Population: The ITT population included all participants who have taken at least 1 dose of RPV, regardless of their compliance with the protocol and adherence to the dosing regimens.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Rilpivirine (RPV) (TMC278-C204 [C204]) | Number of Participants With Grade 3/4 Events of Rash Irrespective of Causality | 0 Participants |
| RPV (TMC278-TiDP6-C209 [C209] and TMC278-TiDP6-C215 [C215]) | Number of Participants With Grade 3/4 Events of Rash Irrespective of Causality | 0 Participants |
Secondary
Change From Baseline in CD4+ Cell Count for Non-Completer Equals Failure (NC=F) Approach Until Week 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).
Time frame: Baseline up to weeks 96, 192, 288, 336
Population: The ITT population included all participants who have taken at least 1 dose of RPV, regardless of their compliance with the protocol and adherence to the dosing regimen. Here 'number of participants analyzed' signifies number of participants analyzed in this outcome measure. Here 'number analyzed' included all participants evaluable at specified timepoint categories.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Rilpivirine (RPV) (TMC278-C204 [C204]) | Change From Baseline in CD4+ Cell Count for Non-Completer Equals Failure (NC=F) Approach Until Week 336 | Week 96 | 69.76 cells/mcL | Standard Error 19.372 |
| Rilpivirine (RPV) (TMC278-C204 [C204]) | Change From Baseline in CD4+ Cell Count for Non-Completer Equals Failure (NC=F) Approach Until Week 336 | Week 288 | 92.12 cells/mcL | Standard Error 22.809 |
| Rilpivirine (RPV) (TMC278-C204 [C204]) | Change From Baseline in CD4+ Cell Count for Non-Completer Equals Failure (NC=F) Approach Until Week 336 | Week 192 | 133.56 cells/mcL | Standard Error 21.906 |
| Rilpivirine (RPV) (TMC278-C204 [C204]) | Change From Baseline in CD4+ Cell Count for Non-Completer Equals Failure (NC=F) Approach Until Week 336 | Week 336 | 70.69 cells/mcL | Standard Error 23.558 |
| RPV (TMC278-TiDP6-C209 [C209] and TMC278-TiDP6-C215 [C215]) | Change From Baseline in CD4+ Cell Count for Non-Completer Equals Failure (NC=F) Approach Until Week 336 | Week 336 | 49.24 cells/mcL | Standard Error 16.688 |
| RPV (TMC278-TiDP6-C209 [C209] and TMC278-TiDP6-C215 [C215]) | Change From Baseline in CD4+ Cell Count for Non-Completer Equals Failure (NC=F) Approach Until Week 336 | Week 96 | 42.19 cells/mcL | Standard Error 11.525 |
| RPV (TMC278-TiDP6-C209 [C209] and TMC278-TiDP6-C215 [C215]) | Change From Baseline in CD4+ Cell Count for Non-Completer Equals Failure (NC=F) Approach Until Week 336 | Week 192 | 91.69 cells/mcL | Standard Error 15.563 |
| RPV (TMC278-TiDP6-C209 [C209] and TMC278-TiDP6-C215 [C215]) | Change From Baseline in CD4+ Cell Count for Non-Completer Equals Failure (NC=F) Approach Until Week 336 | Week 288 | 63.33 cells/mcL | Standard Error 17.132 |
Secondary
Change From Baseline in Cluster of Differentiation 4 (CD4+) Cell Count for Observed Case Approach Until Week 336
The immunologic assessment was determined by change from baseline in CD4+ cell count for observed case approach.
Time frame: Baseline up to weeks 96, 192, 288, 336
Population: The ITT population included all participants who have taken at least 1 dose of RPV, regardless of their compliance with the protocol and adherence to the dosing regimen. Here 'number of participants analyzed' signifies number of participants analyzed in this outcome measure. Here 'number analyzed' included all participants evaluable at specified timepoint categories.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Rilpivirine (RPV) (TMC278-C204 [C204]) | Change From Baseline in Cluster of Differentiation 4 (CD4+) Cell Count for Observed Case Approach Until Week 336 | Week 96 | 72.63 cells/microliter (cells/mcL) | Standard Error 20.581 |
| Rilpivirine (RPV) (TMC278-C204 [C204]) | Change From Baseline in Cluster of Differentiation 4 (CD4+) Cell Count for Observed Case Approach Until Week 336 | Week 192 | 148.76 cells/microliter (cells/mcL) | Standard Error 24.111 |
| Rilpivirine (RPV) (TMC278-C204 [C204]) | Change From Baseline in Cluster of Differentiation 4 (CD4+) Cell Count for Observed Case Approach Until Week 336 | Week 288 | 122.29 cells/microliter (cells/mcL) | Standard Error 29.628 |
| Rilpivirine (RPV) (TMC278-C204 [C204]) | Change From Baseline in Cluster of Differentiation 4 (CD4+) Cell Count for Observed Case Approach Until Week 336 | Week 336 | 161.73 cells/microliter (cells/mcL) | Standard Error 39.851 |
| RPV (TMC278-TiDP6-C209 [C209] and TMC278-TiDP6-C215 [C215]) | Change From Baseline in Cluster of Differentiation 4 (CD4+) Cell Count for Observed Case Approach Until Week 336 | Week 336 | 76.49 cells/microliter (cells/mcL) | Standard Error 40.484 |
| RPV (TMC278-TiDP6-C209 [C209] and TMC278-TiDP6-C215 [C215]) | Change From Baseline in Cluster of Differentiation 4 (CD4+) Cell Count for Observed Case Approach Until Week 336 | Week 96 | 55.91 cells/microliter (cells/mcL) | Standard Error 13.425 |
| RPV (TMC278-TiDP6-C209 [C209] and TMC278-TiDP6-C215 [C215]) | Change From Baseline in Cluster of Differentiation 4 (CD4+) Cell Count for Observed Case Approach Until Week 336 | Week 288 | 101.50 cells/microliter (cells/mcL) | Standard Error 24.108 |
| RPV (TMC278-TiDP6-C209 [C209] and TMC278-TiDP6-C215 [C215]) | Change From Baseline in Cluster of Differentiation 4 (CD4+) Cell Count for Observed Case Approach Until Week 336 | Week 192 | 132.73 cells/microliter (cells/mcL) | Standard Error 21.989 |
Secondary
Number of Participants With AEs Related to Rilpivirine (RPV)
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.
Time frame: Up to 7 years
Population: The ITT population included all participants who have taken at least 1 dose of RPV, regardless of their compliance with the protocol and adherence to the dosing regimens.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Rilpivirine (RPV) (TMC278-C204 [C204]) | Number of Participants With AEs Related to Rilpivirine (RPV) | 7 Participants |
| RPV (TMC278-TiDP6-C209 [C209] and TMC278-TiDP6-C215 [C215]) | Number of Participants With AEs Related to Rilpivirine (RPV) | 16 Participants |
Secondary
Number of Participants With Serious Adverse Events (SAEs)
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.
Time frame: Up to 7 years
Population: The ITT population included all participants who have taken at least 1 dose of RPV, regardless of their compliance with the protocol and adherence to the dosing regimens.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Rilpivirine (RPV) (TMC278-C204 [C204]) | Number of Participants With Serious Adverse Events (SAEs) | 9 Participants |
| RPV (TMC278-TiDP6-C209 [C209] and TMC278-TiDP6-C215 [C215]) | Number of Participants With Serious Adverse Events (SAEs) | 14 Participants |
Secondary
Time To Treatment Failure
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.
Time frame: Up to Week 360
Population: The ITT population included all participants who have taken at least 1 dose of RPV, regardless of their compliance with the protocol and adherence to the dosing regimen.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Rilpivirine (RPV) (TMC278-C204 [C204]) | Time To Treatment Failure | >= 50 copies/mL | 1795.7 days | Standard Error 70.03 |
| Rilpivirine (RPV) (TMC278-C204 [C204]) | Time To Treatment Failure | >= 200 copies/mL | 1868.7 days | Standard Error 63.29 |
| RPV (TMC278-TiDP6-C209 [C209] and TMC278-TiDP6-C215 [C215]) | Time To Treatment Failure | >= 50 copies/mL | 1694.1 days | Standard Error 59.42 |
| RPV (TMC278-TiDP6-C209 [C209] and TMC278-TiDP6-C215 [C215]) | Time To Treatment Failure | >= 200 copies/mL | 1637.5 days | Standard Error 42.42 |
Secondary
Time to Virologic Rebound
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 frame: Up to Week 360
Population: The ITT population included all participants who have taken at least 1 dose of RPV, regardless of their compliance with the protocol and adherence to the dosing regimens.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Rilpivirine (RPV) (TMC278-C204 [C204]) | Time to Virologic Rebound | >= 50 copies/mL | 1670.6 days | Standard Error 51.32 |
| Rilpivirine (RPV) (TMC278-C204 [C204]) | Time to Virologic Rebound | >= 200 copies/mL | 1901.3 days | Standard Error 47.19 |
| RPV (TMC278-TiDP6-C209 [C209] and TMC278-TiDP6-C215 [C215]) | Time to Virologic Rebound | >= 50 copies/mL | 1939.3 days | Standard Error 52.43 |
| RPV (TMC278-TiDP6-C209 [C209] and TMC278-TiDP6-C215 [C215]) | Time to Virologic Rebound | >= 200 copies/mL | 1877.3 days | Standard Error 25.93 |