| ID | Type | Description | Link |
|---|---|---|---|
| TMC278-C204 | Other Identifier | Tibotec Pharmaceuticals, Ireland | |
| R278474-C204 | Other Identifier | Tibotec Pharmaceuticals, Ireland |
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The purpose of this study is to evaluate the dose-response relationship of antiviral activity after 48 weeks treatment with 3 different dose regimens of TMC278.
This is a randomized (the study medication is assigned by chance), active controlled (participants are assigned to either a recognized effective treatment or the study medication) study. This study consists of 3 phases: screening phase (4 weeks), treatment phase (96 weeks), and follow up phase (4 weeks). In the treatment phase, participants will be randomly assigned to 1 of the 4 treatment groups: (1) TMC278 25 mg, (2) TMC278 75 mg, (3) TMC278 150 mg, or (4) efavirnez (control group); along with investigator selected 2 non-nucleoside reverse transcriptase inhibitor (NRTIs) until Week 96. TMC278 will be assigned by double-blinded fashion (participant and investigator are not aware of the TMC278 dose what participants will receive) and efavirnez will be assigned by open-label fashion (all people know what treatment participants will receive). After Week 96, 3 optional open-label (all people know the identity of the intervention) extension periods will be conducted to collect long term safety and effectiveness data of TMC278. 3 optional extension periods are: first optional extension period (all participants will receive TMC278 75 mg + 2 NRTIs from Week 96 to Week144); second optional extension period (all participants will receive TMC278 25 mg + 2 NRTIs from Week 144 to Week 240); and third optional extension period (all participants will receive TMC278 25 mg + 2 NRTIs from Week 240 until TMC278 is commercially available). Participants on efavirenz group will have the option to continue on efavirenz + 2 NRTIs until the total treatment duration of 240 weeks. Safety evaluations will include assessment of adverse events, clinical laboratory tests, electrocardiogram, physical examination, and vital signs which will be monitored throughout the study. The maximum duration of the study will be 104, 152, or 248 weeks, plus the optional third extension period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TMC278 25 mg | Experimental | Participants will receive TMC278 25 mg once daily up to Week 96. Later on, participants will receive TMC278 75 mg once daily up to Week 144 and then TMC278 25 mg once daily up to Week 240. |
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| TMC278 75 mg | Experimental | Participants will receive TMC278 75 mg once daily up to Week 144. Later on, participants will receive TMC278 25 mg once daily up to Week 240. |
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| TMC278 150 mg | Experimental | Participants will receive TMC278 150 mg once daily up to Week 96. Later on, participants will receive TMC278 75 mg once daily up to Week 144 and then TMC278 25 mg once daily up to Week 240. |
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| Efavirenz | Active Comparator | Participants will receive efavirenz 600 mg once daily up to Week 96. Later on, participants will have an option to continue on efavirenz until Week 144 or until Week 240. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TMC278 25 mg | Drug | TMC278 25 mg tablet will be administered once daily. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Virologic Response at Week 48 (Viral Load Less Than 50 Copies Per mL) - as Defined by the Time to Loss of Virologic Response (TLOVR) Algorithm | The TLOVR algorithm was used to derive response, ie, response and loss of response needed to be confirmed at 2 consecutive visits and participants who permanently discontinued were considered nonresponders. Participants with intermittent missing viral load values were considered responders if the preceeding and succeeding visits indicated response. In all other cases, intermittent values were imputed with nonresponse. Resuppression after confirmed virologic failure was considered as failure in this algorithm. | Week 48 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Virologic Response at Week 96 (Viral Load Less Than 50 Copies Per mL) - as Defined by the Time to Loss of Virologic Response (TLOVR) Algorithm | The TLOVR algorithm was used to derive response, ie, response and loss of response needed to be confirmed at 2 consecutive visits and participants who permanently discontinued were considered nonresponders. Participants with intermittent missing viral load values were considered responders if the preceeding and succeeding visits indicated response. In all other cases, intermittent values were imputed with nonresponse. Resuppression after confirmed virologic failure was considered as failure in this algorithm. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tibotec Pharmaceuticals, Ireland Clinical Trial | Tibotec Pharmaceuticals, Ireland | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beverly Hills | California | United States | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19926964 | Derived | Pozniak AL, Morales-Ramirez J, Katabira E, Steyn D, Lupo SH, Santoscoy M, Grinsztejn B, Ruxrungtham K, Rimsky LT, Vanveggel S, Boven K; TMC278-C204 Study Group. Efficacy and safety of TMC278 in antiretroviral-naive HIV-1 patients: week 96 results of a phase IIb randomized trial. AIDS. 2010 Jan 2;24(1):55-65. doi: 10.1097/QAD.0b013e32833032ed. |
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368 participants were randomly assigned to 4 treatment groups (TMC278 25 mg: 93; TMC278 75 mg: 95; TMC278 150 mg: 91; and Efavirenz: 89). Participant flow through Week 240 was reported for the combined TMC278 and Efavirenz groups, as all TMC278 participants were switched after Week 96 initially to 75 mg and subsequently to 25 mg dose.
368 participants were enrolled at multiple centers in different countries.
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| ID | Title | Description |
|---|---|---|
| FG000 | All TMC278 | TMC278 25 mg, 75 mg, and 150 mg once daily |
| FG001 | Efavirenz | Efavirenz 600 mg once daily |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| TMC278 75 mg |
| Drug |
TMC278 75 mg (1 X 25 mg + 1 X 50 mg) tablets will be administered once daily. |
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| TMC278 150 mg | Drug | TMC278 150 mg (1 X 50 mg + 1 X 100 mg) tablets will be administered once daily. |
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| Efavirenz | Drug | Efavirenz 600 mg (1 x 600 mg tablet or 3 x 200 mg capsules, depending on formulation locally available) will be administered once daily. |
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| Non-nucleoside reverse transcriptase inhibitor (NRTIs) | Drug | Investigator selected 2 NRTIs: (1) Zidovudine and lamivudine (Combivir) and (2) tenofovir disoproxil fumarate and emtricitabine (Truvada) will be administered as per the package inserts, along with the TMC278 during the study period. |
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| Week 96 |
| Number of Participants With Virologic Response at Week 96 (Viral Load Less Than 50 Copies Per mL) - Snapshot Analysis | The analysis is based on the last observed viral load data within the Week 96 window. Virologic response is defined as a viral load less than 50 copies/mL. Missing viral load was considered as non-response. | Week 96 |
| Number of Participants With Virologic Response at Week 240 (Viral Load Less Than 50 Copies Per mL) - as Defined by the Time to Loss of Virologic Response (TLOVR) Algorithm | The TLOVR algorithm was used to derive response, ie, response and loss of response needed to be confirmed at 2 consecutive visits and participants who permanently discontinued were considered nonresponders. Participants with intermittent missing viral load values were considered responders if the preceeding and succeeding visits indicated response. In all other cases, intermittent values were imputed with nonresponse. Resuppression after confirmed virologic failure was considered as failure in this algorithm. | Week 240 |
| Number of Participants With Virologic Response at Week 240 (Viral Load Less Than 50 Copies Per mL) - Snapshot Analysis | The analysis is based on the last observed viral load data within the Week 240 window. Virologic response is defined as a viral load less than 50 copies/mL. Missing viral load was considered as non-response. | Week 240 |
| Number of Participants With Virologic Response at Week 240 (Viral Load Less Than 400 Copies/mL) - as Defined by the Time to Loss of Virologic Response (TLOVR) Algorithm | The TLOVR algorithm was used to derive response, ie, response and loss of response needed to be confirmed at 2 consecutive visits and participants who permanently discontinued were considered nonresponders. Participants with intermittent missing viral load values were considered responders if the preceeding and succeeding visits indicated response. In all other cases, intermittent values were imputed with nonresponse. Resuppression after confirmed virologic failure was considered as failure in this algorithm. | Week 240 |
| Change From Baseline in CD4+ Cell Count (Absolute) at Week 96 | Change from baseline in CD4+ cell count was imputed in case of missing values: in case of premature discontinuation, data were imputed with the baseline value after discontinuation (i.e. change=0, Non-Completer [NC] = Failure); otherwise last observation carried forward was applied. | Baseline (Day 1 of Week 0) to Week 96 |
| Change From Baseline in CD4+ Cell Count (Relative) at Week 96 | Change from baseline in CD4+ cell count was imputed in case of missing values: in case of premature discontinuation, data were imputed with the baseline value after discontinuation (i.e. change=0, Non-Completer [NC] = Failure); otherwise last observation carried forward was applied. | Baseline (Day 1 of Week 0) to Week 96 |
| Change From Baseline in CD4+ Cell Count (Absolute) at Week 240 | Change from baseline in CD4+ cell count was imputed in case of missing values: in case of premature discontinuation, data were imputed with the baseline value after discontinuation (i.e. change=0, Non-Completer [NC] = Failure); otherwise last observation carried forward was applied. | Baseline (Day 1 of Week 0) to Week 240 |
| Change From Baseline in CD4+ Cell Count (Relative) at Week 240 | Change from baseline in CD4+ cell count was imputed in case of missing values: in case of premature discontinuation, data were imputed with the baseline value after discontinuation (i.e. change=0, Non-Completer [NC] = Failure); otherwise last observation carried forward was applied. | Baseline (Day 1 of week 0) to Week 240 |
| Number of Participants With Virologic Failure for the Resistance Determinations by Developing Mutations: First Available On-Treatment Genotypic Data After Failure | Virologic failure for the resistance determinations was defined as a viral load greater than 0.5 log10 copies /mL above the nadir with a minimum of 500 copies/mL. For this study, treatment-emergent mutations (for at least one treatment) are presented as Resistance associated mutation (RAMs): i) Non-nucleotide reverse transcriptase inhibitor (NNRTI) RAMs, ii) Nucleoside/tide reverse transcriptase inhibitor (N[t]RTI RAMs). | Week 240 |
| Area Under the Plasma Concentration Time Curve From Time 0 to 24 Hours (AUC24h) for TMC278 | For each participant, a single value for area under the plasma concentration-time curve from time of administration up to 24 hours post dosing (AUC24h) of TMC278 was estimated from a population pharmacokinetic model, based on all samples collected throughout the trial up to Week 96. | Up to Week 96 |
| Trough Plasma Concentration (Ctrough) for TMC278 | For each participant, a single value for trough (i.e. predose) plasma concentration (Ctrough) of TMC278 was estimated from a population pharmacokinetic model, based on samples collected throughout the trial up to Week 96. | Up to Week 96 |
| Number of Participants With Virologic Response (Viral Load Less Than 50 Copies Per mL) - as Defined by the Time to Loss of Virologic Response (TLOVR) Algorithm, by Area Under the Plasma Concentration Time Curve From Time 0 to 24 Hours (AUC24h) Quartiles | Quartile 1, 2, 3 and 4 of AUC24h means the quartile with the lowest 25%, 26-50%, 51-75% and the highest 25% of AUC24h values, respectively, irrespective of the different doses of TMC278. For each participant, a single value for area under the plasma concentration-time curve from time of administration up to 24 hours post dosing (AUC24h) of TMC278 was estimated from a population pharmacokinetic model, based on all samples collected throughout the trial up to Week 96. Virologic response was calculated by time to loss of virologic response (TLOVR) algorithm. | Up to Week 96 |
| Washington D.C. |
| District of Columbia |
| United States |
| Orlando | Florida | United States |
| Tampa | Florida | United States |
| Atlanta | Georgia | United States |
| Stony Brook | New York | United States |
| Winston-Salem | North Carolina | United States |
| Addison | Texas | United States |
| Seattle | Washington | United States |
| Buenos Aires | Argentina |
| Rosario | Argentina |
| Vienna | Austria |
| Campinas | Brazil |
| Curitiba | Brazil |
| Pinheiros | Brazil |
| Rio de Janeiro | Brazil |
| São Paulo | Brazil |
| Beijing | China |
| Paris | France |
| Tourcoing | France |
| Berlin | Germany |
| Cologne | Germany |
| Freiburg im Breisgau | Germany |
| München | Germany |
| Mexico City | Mexico |
| San Juan | Puerto Rico |
| Kazan' | Russia |
| Moscow | Russia |
| Nizhny Novgorod | Russia |
| Saint Petersburg | Russia |
| Volgograd | Russia |
| Bloemfontein | South Africa |
| Cape Town | South Africa |
| Johannesburg | South Africa |
| Bangkok | Thailand |
| Chiang Mai | Thailand |
| Khon Kaen | Thailand |
| Kampala | Uganda |
| London | United Kingdom |
| Manchester | United Kingdom |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | TMC278 25 mg | TMC278 25 mg once daily |
| BG001 | TMC278 75 mg | TMC278 75 mg once daily |
| BG002 | TMC 150 mg | TMC278 150 mg once daily |
| BG003 | Efavirenz | Efavirenz 600 mg once daily |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region Enroll | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Virologic Response at Week 48 (Viral Load Less Than 50 Copies Per mL) - as Defined by the Time to Loss of Virologic Response (TLOVR) Algorithm | The TLOVR algorithm was used to derive response, ie, response and loss of response needed to be confirmed at 2 consecutive visits and participants who permanently discontinued were considered nonresponders. Participants with intermittent missing viral load values were considered responders if the preceeding and succeeding visits indicated response. In all other cases, intermittent values were imputed with nonresponse. Resuppression after confirmed virologic failure was considered as failure in this algorithm. | Intent to treat population: Participants who received at least 1 dose of study medication. | Posted | Number | Participants | Week 48 |
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| Secondary | Number of Participants With Virologic Response at Week 96 (Viral Load Less Than 50 Copies Per mL) - as Defined by the Time to Loss of Virologic Response (TLOVR) Algorithm | The TLOVR algorithm was used to derive response, ie, response and loss of response needed to be confirmed at 2 consecutive visits and participants who permanently discontinued were considered nonresponders. Participants with intermittent missing viral load values were considered responders if the preceeding and succeeding visits indicated response. In all other cases, intermittent values were imputed with nonresponse. Resuppression after confirmed virologic failure was considered as failure in this algorithm. | Intent to treat population: Participants who received at least 1 dose of study medication. | Posted | Number | Participants | Week 96 |
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| Secondary | Number of Participants With Virologic Response at Week 96 (Viral Load Less Than 50 Copies Per mL) - Snapshot Analysis | The analysis is based on the last observed viral load data within the Week 96 window. Virologic response is defined as a viral load less than 50 copies/mL. Missing viral load was considered as non-response. | Intent to treat population: Participants who received at least 1 dose of study medication. | Posted | Number | Participants | Week 96 |
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| Secondary | Number of Participants With Virologic Response at Week 240 (Viral Load Less Than 50 Copies Per mL) - as Defined by the Time to Loss of Virologic Response (TLOVR) Algorithm | The TLOVR algorithm was used to derive response, ie, response and loss of response needed to be confirmed at 2 consecutive visits and participants who permanently discontinued were considered nonresponders. Participants with intermittent missing viral load values were considered responders if the preceeding and succeeding visits indicated response. In all other cases, intermittent values were imputed with nonresponse. Resuppression after confirmed virologic failure was considered as failure in this algorithm. | Intent to treat population: Participants who received at least 1 dose of study medication. This was measured at Week 240 for the combined TMC278 and Efavirenz groups, as all TMC278 participants were switched after Week 96 initially to 75 mg and subsequently to 25 mg dose. | Posted | Number | Participants | Week 240 |
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| Secondary | Number of Participants With Virologic Response at Week 240 (Viral Load Less Than 50 Copies Per mL) - Snapshot Analysis | The analysis is based on the last observed viral load data within the Week 240 window. Virologic response is defined as a viral load less than 50 copies/mL. Missing viral load was considered as non-response. | Intent to treat population: Participants who received at least 1 dose of study medication. This was measured at Week 240 for the combined TMC278 and Efavirenz groups, as all TMC278 participants were switched after Week 96 initially to 75 mg and subsequently to 25 mg dose. | Posted | Number | Participants | Week 240 |
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| Secondary | Number of Participants With Virologic Response at Week 240 (Viral Load Less Than 400 Copies/mL) - as Defined by the Time to Loss of Virologic Response (TLOVR) Algorithm | The TLOVR algorithm was used to derive response, ie, response and loss of response needed to be confirmed at 2 consecutive visits and participants who permanently discontinued were considered nonresponders. Participants with intermittent missing viral load values were considered responders if the preceeding and succeeding visits indicated response. In all other cases, intermittent values were imputed with nonresponse. Resuppression after confirmed virologic failure was considered as failure in this algorithm. | Intent to treat population: Participants who received at least 1 dose of study medication. This was measured at Week 240 for the combined TMC278 and Efavirenz groups, as all TMC278 participants were switched after Week 96 initially to 75 mg and subsequently to 25 mg dose. | Posted | Number | Participants | Week 240 |
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| Secondary | Change From Baseline in CD4+ Cell Count (Absolute) at Week 96 | Change from baseline in CD4+ cell count was imputed in case of missing values: in case of premature discontinuation, data were imputed with the baseline value after discontinuation (i.e. change=0, Non-Completer [NC] = Failure); otherwise last observation carried forward was applied. | Intent to treat population: Participants who received at least 1 dose of study medication.Efavirenz group, 1 participant was excluded due to missing baseline CD4+ cell count. | Posted | Mean | Standard Deviation | Cells per microliter | Baseline (Day 1 of Week 0) to Week 96 |
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| Secondary | Change From Baseline in CD4+ Cell Count (Relative) at Week 96 | Change from baseline in CD4+ cell count was imputed in case of missing values: in case of premature discontinuation, data were imputed with the baseline value after discontinuation (i.e. change=0, Non-Completer [NC] = Failure); otherwise last observation carried forward was applied. | Intent to treat (ITT) population: Participants who received at least 1 dose of study medication. Efavirenz group, 1 participant was excluded due to missing baseline CD4+ cell count. | Posted | Mean | Standard Deviation | Percentage of CD4+ Cells | Baseline (Day 1 of Week 0) to Week 96 |
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| Secondary | Change From Baseline in CD4+ Cell Count (Absolute) at Week 240 | Change from baseline in CD4+ cell count was imputed in case of missing values: in case of premature discontinuation, data were imputed with the baseline value after discontinuation (i.e. change=0, Non-Completer [NC] = Failure); otherwise last observation carried forward was applied. | ITT population: Participants who received at least 1 dose of study medication. Efavirenz group, 1 participant was excluded due to missing baseline CD4+ cell count. This was measured at Week 240 for the combined TMC278 and Efavirenz groups, as all TMC278 participants were switched after Week 96 initially to 75 mg and subsequently to 25 mg dose. | Posted | Mean | Standard Deviation | Cells per microliter | Baseline (Day 1 of Week 0) to Week 240 |
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| Secondary | Change From Baseline in CD4+ Cell Count (Relative) at Week 240 | Change from baseline in CD4+ cell count was imputed in case of missing values: in case of premature discontinuation, data were imputed with the baseline value after discontinuation (i.e. change=0, Non-Completer [NC] = Failure); otherwise last observation carried forward was applied. | ITT population: Participants who received at least 1 dose of study medication. Efavirenz group, 1 participant was excluded due to missing baseline CD4+ cell count. This was measured at Week 240 for the combined TMC278 and Efavirenz groups, as all TMC278 participants were switched after Week 96 initially to 75 mg and subsequently to 25 mg dose. | Posted | Mean | Standard Deviation | Percentage of CD4+ cells | Baseline (Day 1 of week 0) to Week 240 |
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| Secondary | Number of Participants With Virologic Failure for the Resistance Determinations by Developing Mutations: First Available On-Treatment Genotypic Data After Failure | Virologic failure for the resistance determinations was defined as a viral load greater than 0.5 log10 copies /mL above the nadir with a minimum of 500 copies/mL. For this study, treatment-emergent mutations (for at least one treatment) are presented as Resistance associated mutation (RAMs): i) Non-nucleotide reverse transcriptase inhibitor (NNRTI) RAMs, ii) Nucleoside/tide reverse transcriptase inhibitor (N[t]RTI RAMs). | Intent to treat population: Participants who received at least 1 dose of study medication. This was measured at Week 240 for the combined TMC278 and Efavirenz groups, as all TMC278 participants were switched after Week 96 initially to 75 mg and subsequently to 25 mg dose. | Posted | Number | Participants | Week 240 |
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| Secondary | Area Under the Plasma Concentration Time Curve From Time 0 to 24 Hours (AUC24h) for TMC278 | For each participant, a single value for area under the plasma concentration-time curve from time of administration up to 24 hours post dosing (AUC24h) of TMC278 was estimated from a population pharmacokinetic model, based on all samples collected throughout the trial up to Week 96. | Analysis included participants with sufficient number of pharmacokinetic samples in order to derive population pharmacokinetic parameter. | Posted | Mean | Standard Deviation | ng*h/mL | Up to Week 96 |
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| Secondary | Trough Plasma Concentration (Ctrough) for TMC278 | For each participant, a single value for trough (i.e. predose) plasma concentration (Ctrough) of TMC278 was estimated from a population pharmacokinetic model, based on samples collected throughout the trial up to Week 96. | Analysis included participants with sufficient number of pharnacokintetic samples in order to derive population pharmacokinetic parameter. | Posted | Mean | Standard Deviation | ng/mL | Up to Week 96 |
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| Secondary | Number of Participants With Virologic Response (Viral Load Less Than 50 Copies Per mL) - as Defined by the Time to Loss of Virologic Response (TLOVR) Algorithm, by Area Under the Plasma Concentration Time Curve From Time 0 to 24 Hours (AUC24h) Quartiles | Quartile 1, 2, 3 and 4 of AUC24h means the quartile with the lowest 25%, 26-50%, 51-75% and the highest 25% of AUC24h values, respectively, irrespective of the different doses of TMC278. For each participant, a single value for area under the plasma concentration-time curve from time of administration up to 24 hours post dosing (AUC24h) of TMC278 was estimated from a population pharmacokinetic model, based on all samples collected throughout the trial up to Week 96. Virologic response was calculated by time to loss of virologic response (TLOVR) algorithm. | Analysis included participants who received TMC278 with sufficient number of pharnacokintetic samples in order to derive population pharmacokinetic parameter. Participants who discontinued treatment for reasons other than virological failure were excluded from this analysis. | Posted | Number | Participants | Up to Week 96 |
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Up to 336 weeks for participants in the TMC278 treatment group and up to 260 weeks for participants in the efavirenz treatment group.
Adverse events were reported at Week 240 for the combined TMC278 and Efavirenz groups, as all TMC278 participants were switched after Week 96 initially to 75 mg and subsequently to 25 mg dose.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | All TMC278 | TMC278 25 mg, 75 mg, and 150 mg once daily | 49 | 279 | 241 | 279 | ||
| EG001 | Efavirenz | Efavirenz 600 mg once daily | 17 | 89 | 82 | 89 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 11.0 | Systematic Assessment |
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| Acute myocardial infarction | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
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| Leukopenia | Blood and lymphatic system disorders | MedDRA 11.0 | Systematic Assessment |
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| Neutropenia | Blood and lymphatic system disorders | MedDRA 11.0 | Systematic Assessment |
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| Angina unstable | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
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| Supraventricular tachycardia | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
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| Anal fissure | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
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| Anal fistula | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
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| Appendicitis perforated | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
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| Colitis | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
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| Diarrhoea haemorrhagic | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
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| Intestinal infarction | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
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| Intestinal obstruction | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
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| Pancreatitis | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
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| Pancreatitis acute | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
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| Peritonitis | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
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| Rectal haemorrhage | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
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| Chest pain | General disorders | MedDRA 11.0 | Systematic Assessment |
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| Death | General disorders | MedDRA 11.0 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA 11.0 | Systematic Assessment |
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| Bile duct stone | Hepatobiliary disorders | MedDRA 11.0 | Systematic Assessment |
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| Cholecystitis acute | Hepatobiliary disorders | MedDRA 11.0 | Systematic Assessment |
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| Cholelithiasis | Hepatobiliary disorders | MedDRA 11.0 | Systematic Assessment |
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| Cytolytic hepatitis | Hepatobiliary disorders | MedDRA 11.0 | Systematic Assessment |
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| Hepatitis | Hepatobiliary disorders | MedDRA 11.0 | Systematic Assessment |
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| Hepatitis acute | Hepatobiliary disorders | MedDRA 11.0 | Systematic Assessment |
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| Hydrocholecystis | Hepatobiliary disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Abscess neck | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Arthritis bacterial | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Clostridial infection | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Cytomegalovirus colitis | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Hepatitis C | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Implant site infection | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Lobar pneumonia | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Lung infection | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Malaria | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Meningitis tuberculous | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Osteomyelitis | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Perianal abscess | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Pneumonia streptococcal | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Sepsis syndrome | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Subcutaneous abscess | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
| |
| Brain contusion | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
| |
| Drug toxicity | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
| |
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
| |
| Muscle injury | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
| |
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 11.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 11.0 | Systematic Assessment |
| |
| Blood amylase increased | Investigations | MedDRA 11.0 | Systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Metabolic acidosis | Metabolism and nutrition disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Costochondritis | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Lumbar spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Burkitt's lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | Systematic Assessment |
| |
| Cervix cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | Systematic Assessment |
| |
| Chondrosarcoma metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | Systematic Assessment |
| |
| Kaposi's sarcoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | Systematic Assessment |
| |
| Lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | Systematic Assessment |
| |
| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | Systematic Assessment |
| |
| Uterine leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | Systematic Assessment |
| |
| Epilepsy | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA 11.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Intentional self-injury | Psychiatric disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Major depression | Psychiatric disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Suicide attempt | Psychiatric disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Renal impairment | Renal and urinary disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Ovarian cyst | Reproductive system and breast disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Prostatitis | Reproductive system and breast disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Alveolitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Ovarian cystectomy | Surgical and medical procedures | MedDRA 11.0 | Systematic Assessment |
| |
| Penile prosthesis insertion | Surgical and medical procedures | MedDRA 11.0 | Systematic Assessment |
| |
| Arterial occlusive disease | Vascular disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 11.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Conjunctivitis | Eye disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Body tinea | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Condyloma acuminatum | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Herpes simplex | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Respiratory tract infection viral | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Tinea pedis | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 11.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 11.0 | Systematic Assessment |
| |
| Blood cholesterol increased | Investigations | MedDRA 11.0 | Systematic Assessment |
| |
| Low density lipoprotein increased | Investigations | MedDRA 11.0 | Systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Abnormal dreams | Psychiatric disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Nightmare | Psychiatric disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Seborrhoeic dermatitis | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 11.0 | Systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director | Janssen-Virco BE | 32 14 641418 |
| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068696 | Rilpivirine |
| C098320 | efavirenz |
| C109078 | lamivudine, zidovudine drug combination |
| D000069480 | Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination |
| ID | Term |
|---|---|
| D009570 | Nitriles |
| D009930 | Organic Chemicals |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D000068698 | Tenofovir |
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D000068679 | Emtricitabine |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D000225 | Adenine |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |
Not provided
Not provided
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Europe, USA and Russia |
|
| Latin America |
|
|
| Regression, Logistic |
This model with factors treatment, region, and N(t)RTIs used, and baseline viral load as covariate. |
| 0.56 |
The significance level for each comparison was 5% (two-sided). No further adjustment of this significance level was applied. |
| Difference in response rate |
| -2.3 |
| 2-Sided |
| 95 |
| -13.6 |
| 9.0 |
| No |
| Superiority or Other |
| Regression, Logistic | This model with factors treatment, region, and N(t)RTIs used, and baseline viral load as covariate. | 0.62 | The significance level for each comparison was 5% (two-sided). No further adjustment of this significance level was applied. | Difference in response rate | -2.8 | 2-Sided | 95 | -14.0 | 8.4 | No | Superiority or Other |
| Regression, Logistic | This model with factors treatment, region, and N(t)RTIs used, and baseline viral load as covariate. | 0.80 | The significance level for each comparison was 5% (two-sided). No further adjustment of this significance level was applied. | Difference in response rate | -1.5 | 2-Sided | 95 | -10.5 | 7.5 | No | Superiority or Other |
TMC278 25 mg, 75 mg, and 150 mg once daily
| OG004 | Efavirenz | Efavirenz 600 mg once daily |
|
|
|
Efavirenz 600 mg once daily
|
|
| Participants |
|
|
|
|
| Participants |
|
|
| Efavirenz |
Efavirenz 600 mg once daily |
|
|
| OG004 |
| Efavirenz |
Efavirenz 600 mg once daily |
|
|
|
|
|
|
|
TMC278 25 mg, 75 mg, and 150 mg once daily |
| OG003 | AUC24h Quartile 4 | TMC278 25 mg, 75 mg, and 150 mg once daily |
|
|