Trial · NCT00543725
TMC278-TiDP6-C215: A Clinical Trial in Treatment Naive HIV-subjects Patients Comparing TMC278 to Efavirenz in Combination With 2 Nucleoside/Nucleotide Reverse Transcriptase Inhibitors
NCT00543725, Phase 3, Completed, Tibotec Pharmaceuticals, Ireland; results first posted 2011-07-12
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. TMC278-TiDP6-C215: A Clinical Trial in Treatment Naive HIV-subjects Patients Comparing TMC278 to Efavirenz in Combination With 2 Nucleoside/Nucleotide Reverse Transcriptase Inhibitors. Trials, record NCT00543725. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00543725
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- TMC278-TiDP6-C215: A Clinical Trial in Treatment Naive HIV-subjects Patients Comparing TMC278 to Efavirenz in Combination With 2 Nucleoside/Nucleotide Reverse Transcriptase Inhibitors
- NCT number
- NCT00543725
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 680 participants, actual
- Lead sponsor
- Tibotec Pharmaceuticals, Ireland
- Conditions
- HIV Infections, HIV-1
- Interventions
- TMC278, efavirenz
- First posted
- 2007-10-15
- Last updated
- 2016-04-01
- Results first posted
- 2011-07-12
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Virological Response (Intent-to-Treat - Time to Loss of Virologic Response [TLOVR], <50 Copies Per mL) at Week 48 | Week 48 | Virological response is defined as confirmed plasma viral load less than (\<) 50 human immunodeficiency virus-1 (HIV-1) (ribonucleic acid \[RNA\]) copies/milliliter (ml) at Week 48. The TLOVR algorithm was used to derive response. Response needed to be confirmed at 2 consecutive visits and participants who permanently discontinued were considered nonresponders after discontinuation. Resuppression after confirmed virologic failure was considered as failure. Virologic Failure includes participants who were rebounder (confirmed viral load \>= 50 copies/ml after being responder) or who were never suppressed (no confirmed viral load \<50 copies/ml). |
| Secondary | Number of Participants With Virological Response (Intent-to-Treat - Snapshot, <50 Copies Per mL) at Week 48 | Week 48 | The analysis is based on the last observed viral load (VL) data within the Week 48 window. Virologic response is defined as a VL\<50 copies/mL (observed case). Missing VL was considered as non-response. Virologic Failure includes subjects who had VL\>=50 copies/mL in the Wk 48 window, subjects who discontinued early due to lack or loss of efficacy, subjects who discontinued for reasons other than an adverse event, death or lack or loss of efficacy and at the time of discontinuation had a VL\>=50 copies/mL and subjects who had a switch in background regimen that was not permitted by the protocol. |
| Secondary | Number of Participants With Virological Response (Intent-to-Treat - Time to Loss of Virologic Response [TLOVR], <50 Copies Per mL) at Week 96 | Week 96 | |
| Secondary | Number of Participants With Virological Response (Intent-to-Treat - Snapshot, <50 Copies Per mL) at Week 96 | Week 96 | |
| Secondary | Number of Participants With Virological Response (Observed, <50 Copies/mL) at Last On-Treatment Visit (Post-Week 96). | Variable, ranging from 3 months up to maximum 18 months for TMC278 and 12 months for Efavirenz | Virological response is defined as (observed) plasma viral load less than 50 human immunodeficiency virus-type 1 (HIV-1) ribonucleic acid (RNA) copies per mL at the last on-treatment post-Week 96 visit. |
| Secondary | Number of Participants With Virological Response (Intent-to-Treat - Time to Loss of Virologic Response [TLOVR], <400 Copies Per mL) at Week 48 | Week 48 | Virological response is defined as confirmed plasma viral load \< 400 HIV-1 (RNA) copies/mL at Week 48. The TLOVR algorithm was used to derive response. Response needed to be confirmed at 2 consecutive visits and participants who permanently discontinued were considered nonresponders after discontinuation. Resuppression after confirmed virologic failure was considered as failure. Virologic Failure includes participants who were rebounder (confirmed viral load \>= 400 copies/mL after being responder) or who were never suppressed (no confirmed viral load \<400 copies/mL). |
| Secondary | Number of Participants With Virological Response (Intent-to-Treat - Time to Loss of Virologic Response [TLOVR], <400 Copies Per mL) at Week 96 | Week 96 | Virological response is defined as confirmed plasma viral load \< 400 HIV-1 (RNA) copies/mL at Week 96. The TLOVR algorithm was used to derive response. Response needed to be confirmed at 2 consecutive visits and participants who permanently discontinued were considered nonresponders after discontinuation. Resuppression after confirmed virologic failure was considered as failure. Virologic Failure includes participants who were rebounder (confirmed viral load \>= 400 copies/mL after being responder) or who were never suppressed (no confirmed viral load \<400 copies/mL). |
| Secondary | Mean Change From Baseline to Week 48 and Week 96 in Absolute and Relative CD4+ Cell Counts (Using Imputed Data) | Baseline, Week 48, and 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. |
| Secondary | Number of Participants With Virologic Failure for the Resistance Determinations by Developing Mutations: First Available On-Treatment Genotypic Data After Failure | Week 96 | Virologic failure for the resistance determinations was defined as lack of virologic response (never having had 2 consecutive plasma viral load \<50 copies/mL) and plasma viral load increase of \>=0.5 log 10 copies/mL above nadir (i.e., never suppressed), or confirmed loss of virologic response (2 consecutive plasma viral load \>=50 copies/mL after having had 2 consecutive plasma viral load \<50 copies/mL; i.e., rebounder), or discontinued with a last observed on-treatment plasma viral load \>=50 copies/mL after having had 2 consecutive plasma viral load \<50 copies/mL. For this study, treatment-emergent reverse transcriptase (RT) resistance associated mutations (RAMs) occurring in at least 2 virologic failures (for at least one treatment group) for the following lists are presented: i) Extended list of Non-nucleoside reverse transcriptase inhibitor (NNRTI RAMs) ii) IAS-USA list of Nucleoside/tide reverse transcriptase inhibitor (N\[t\]RTI RAMs). |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Virological Response (Intent-to-Treat - Time to Loss of Virologic Response [TLOVR], <50 Copies Per mL) at Week 48 | Week 48 | The Intent-to-Treat analysis set was considered the primary efficacy analysis set. | Participants | NUMBER |
| SECONDARY | Number of Participants With Virological Response (Intent-to-Treat - Snapshot, <50 Copies Per mL) at Week 48 | Week 48 | The Intent-to-Treat analysis set was considered the primary efficacy analysis set. | Participants | NUMBER |
| SECONDARY | Number of Participants With Virological Response (Intent-to-Treat - Time to Loss of Virologic Response [TLOVR], <50 Copies Per mL) at Week 96 | Week 96 | The Intent-to-Treat analysis set was considered the primary efficacy analysis set. | Participants | NUMBER |
| SECONDARY | Number of Participants With Virological Response (Intent-to-Treat - Snapshot, <50 Copies Per mL) at Week 96 | Week 96 | The Intent-to-Treat analysis set was considered the primary efficacy analysis set. | Participants | NUMBER |
| SECONDARY | Number of Participants With Virological Response (Observed, <50 Copies/mL) at Last On-Treatment Visit (Post-Week 96). | Variable, ranging from 3 months up to maximum 18 months for TMC278 and 12 months for Efavirenz | Participants with at least 1 Post-Week 96 visit were included in the analysis. | Participants | NUMBER |
| SECONDARY | Number of Participants With Virological Response (Intent-to-Treat - Time to Loss of Virologic Response [TLOVR], <400 Copies Per mL) at Week 48 | Week 48 | The Intent-to-Treat analysis set was considered the primary efficacy analysis set. | Participants | NUMBER |
| SECONDARY | Number of Participants With Virological Response (Intent-to-Treat - Time to Loss of Virologic Response [TLOVR], <400 Copies Per mL) at Week 96 | Week 96 | The Intent-to-Treat analysis set was considered the primary efficacy analysis set. | Participants | NUMBER |
| SECONDARY | Mean Change From Baseline to Week 48 and Week 96 in Absolute and Relative CD4+ Cell Counts (Using Imputed Data) | Baseline, Week 48, and Week 96 | The Intent-to-Treat analysis set was considered the primary efficacy analysis set. | cells per microliter | MEAN |
| SECONDARY | Number of Participants With Virologic Failure for the Resistance Determinations by Developing Mutations: First Available On-Treatment Genotypic Data After Failure | Week 96 | The Intent-to-Treat analysis set was considered the primary efficacy analysis set. Here N (Number of Participants Analyzed) signifies number of Participants who were evaluable (had data) for this outcome. | Participants | NUMBER |
Source ClinicalTrials.gov
Results by group74
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Virological Response (Intent-to-Treat - Time to Loss of Virologic Response [TLOVR], <50 Copies Per mL) at Week 48 | TMC278 | Responder | 291 | Participants | |
| Number of Participants With Virological Response (Intent-to-Treat - Time to Loss of Virologic Response [TLOVR], <50 Copies Per mL) at Week 48 | Efavirenz | Responder | 276 | Participants | |
| Number of Participants With Virological Response (Intent-to-Treat - Time to Loss of Virologic Response [TLOVR], <50 Copies Per mL) at Week 48 | TMC278 | Virologic failure | 24 | Participants | |
| Number of Participants With Virological Response (Intent-to-Treat - Time to Loss of Virologic Response [TLOVR], <50 Copies Per mL) at Week 48 | Efavirenz | Virologic failure | 18 | Participants | |
| Number of Participants With Virological Response (Intent-to-Treat - Time to Loss of Virologic Response [TLOVR], <50 Copies Per mL) at Week 48 | TMC278 | Death | 1 | Participants | |
| Number of Participants With Virological Response (Intent-to-Treat - Time to Loss of Virologic Response [TLOVR], <50 Copies Per mL) at Week 48 | Efavirenz | Death | 3 | Participants | |
| Number of Participants With Virological Response (Intent-to-Treat - Time to Loss of Virologic Response [TLOVR], <50 Copies Per mL) at Week 48 | TMC278 | Discontinued due to AE | 8 | Participants | |
| Number of Participants With Virological Response (Intent-to-Treat - Time to Loss of Virologic Response [TLOVR], <50 Copies Per mL) at Week 48 | Efavirenz | Discontinued due to AE | 21 | Participants | |
| Number of Participants With Virological Response (Intent-to-Treat - Time to Loss of Virologic Response [TLOVR], <50 Copies Per mL) at Week 48 | TMC278 | Discontinued due to other reason than AE | 16 | Participants | |
| Number of Participants With Virological Response (Intent-to-Treat - Time to Loss of Virologic Response [TLOVR], <50 Copies Per mL) at Week 48 | Efavirenz | Discontinued due to other reason than AE | 20 | Participants |
1 to 10 of 74Source ClinicalTrials.gov
See all 74 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | TMC278 | 340 | |
| Overall Study | STARTED | Efavirenz | 338 | |
| Overall Study | COMPLETED | TMC278 | 272 | |
| Overall Study | COMPLETED | Efavirenz | 264 | |
| Overall Study | NOT COMPLETED | TMC278 | 68 | |
| Overall Study | NOT COMPLETED | Efavirenz | 74 |
Source ClinicalTrials.gov
Adverse events220
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Nasopharyngitis | Infections and infestations | TMC278 | 50 | 340 | |
| other | Nasopharyngitis | Infections and infestations | Efavirenz | 47 | 338 | |
| other | Upper respiratory tract infection | Infections and infestations | TMC278 | 43 | 340 | |
| other | Upper respiratory tract infection | Infections and infestations | Efavirenz | 37 | 338 | |
| other | Bronchitis | Infections and infestations | TMC278 | 31 | 340 | |
| other | Bronchitis | Infections and infestations | Efavirenz | 6 | 338 | |
| other | Influenza | Infections and infestations | TMC278 | 32 | 340 | |
| other | Influenza | Infections and infestations | Efavirenz | 30 | 338 | |
| other | Pharyngitis | Infections and infestations | TMC278 | 20 | 340 | |
| other | Pharyngitis | Infections and infestations | Efavirenz | 14 | 338 |
1 to 10 of 220Source ClinicalTrials.gov
See all 220 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | TMC278 | ||
| Total, all-cause mortality | Efavirenz | ||
| Total, other adverse events | TMC278 | 253 | 340 |
| Total, other adverse events | Efavirenz | 259 | 338 |
| Total, serious adverse events | TMC278 | 32 | 340 |
| Total, serious adverse events | Efavirenz | 31 | 338 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| TMC278 vs Efavirenz: Number of Participants With Virological Response (Intent-to-Treat - Time to Loss of Virologic Response [TLOVR], <400 Copies Per mL) at Week 48 | Trial comparisons |
| TMC278 vs Efavirenz: Number of Participants With Virological Response (Observed, <50 Copies/mL) at Last On-Treatment Visit (Post-Week 96). | Trial comparisons |
| TMC278 vs Efavirenz: Number of Participants With Virological Response (Intent-to-Treat - Time to Loss of Virologic Response [TLOVR], <400 Copies Per mL) at Week 96 | Trial comparisons |
| TMC278 vs Efavirenz: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
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