An Open-label Trial With TMC125 in Patients Who Have Virologically Failed in a DUET Trial (TMC125-C206 or TMC125-C216).
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| ClinicalTrials.gov Identifier: NCT00359021 |
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Recruitment Status :
Completed
First Posted : August 1, 2006
Results First Posted : March 7, 2013
Last Update Posted : May 16, 2014
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Sponsor:
Tibotec Pharmaceuticals, Ireland
Information provided by (Responsible Party):
Tibotec Pharmaceuticals, Ireland
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| Study Type | Interventional |
|---|---|
| Study Design | Allocation: Non-Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
| Condition |
HIV-1 |
| Intervention |
Drug: TMC125 |
| Enrollment | 503 |
Participant Flow
| Recruitment Details | |
| Pre-assignment Details | Participants with human immunodeficiency virus - type 1 (HIV-1) infection were enrolled in this study from DUET Study TMC125-C206 or TMC125-C216 and met the definition of virologic failure at Week 24 or later in these studies, or who completed one of the DUET studies after 96 weeks of treatment. |
| Arm/Group Title | DUET PLACEBO | DUET TMC125 |
|---|---|---|
 Arm/Group Description |
Participants who received Placebo in a previous DUET study and received open-label treatment with 200 mg twice daily etravirine, also known as TMC125 (ETR) and 600/100 mg twice daily darunavir (DRV)/low-dose ritonavir (rtv) were referred to as ETR-naïve participants. | Participants who received etravirine, also known as TMC125 (ETR) in a previous DUET study and received open-label treatment with 200 mg twice daily ETR and 600/100 mg twice daily darunavir (DRV)/low-dose ritonavir (rtv) were referred to as ETR-experienced participants. |
| Period Title: Overall Study | ||
| Started | 256 | 247 |
| Completed | 175 | 195 |
| Not Completed | 81 | 52 |
| Reason Not Completed | ||
| Adverse Event | 26 | 8 |
| Subject Non-Compliant | 1 | 2 |
| Subject Ineligible To Continue The Trial | 1 | 0 |
| Subject Reached A Virologic Endpoint | 45 | 32 |
| Withdrawal by Subject | 2 | 9 |
| Lost to Follow-up | 1 | 0 |
| Other | 4 | 1 |
| Pregnancy | 1 | 0 |
Baseline Characteristics
| Arm/Group Title | DUET PLACEBO | DUET TMC125 | Total | |
|---|---|---|---|---|
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Arm/Group Description |
Participants who received Placebo in a previous DUET study and received open-label treatment with 200 mg twice daily etravirine, also known as TMC125 (ETR) and 600/100 mg twice daily darunavir (DRV)/low-dose ritonavir (rtv) were referred to as ETR-naïve participants. | Participants who received etravirine, also known as TMC125 (ETR) in a previous DUET study and received open-label treatment with 200 mg twice daily ETR and 600/100 mg twice daily darunavir (DRV)/low-dose ritonavir (rtv) were referred to as ETR-experienced participants. | Total of all reporting groups | |
| Overall Number of Baseline Participants | 256 | 247 | 503 | |
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Baseline Analysis Population Description |
[Not Specified]
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Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 256 participants | 247 participants | 503 participants | |
| <=18 years |
0 0.0%
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0 0.0%
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0 0.0%
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| Between 18 and 65 years |
252 98.4%
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245 99.2%
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497 98.8%
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| >=65 years |
4 1.6%
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2 0.8%
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6 1.2%
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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| Number Analyzed | 256 participants | 247 participants | 503 participants | |
| 46.9 (8.28) | 46.6 (7.01) | 46.7 (7.68) | ||
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 256 participants | 247 participants | 503 participants | |
| Female |
27 10.5%
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37 15.0%
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64 12.7%
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| Male |
229 89.5%
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210 85.0%
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439 87.3%
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Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts
the PI's rights to discuss or publish trial results after the trial is completed.
The investigator agrees that before he/she publishes any results of this trial, he/she shall provide the sponsor with at least 45 days for full review of the pre-publication manuscript prior to submission of the manuscript to the publisher.
Results Point of Contact
| Name/Title: | SENIOR DIRECTOR R&D |
| Organization: | Tibotec |
| Phone: | 1 609 730-7548 |
| Responsible Party: | Tibotec Pharmaceuticals, Ireland |
| ClinicalTrials.gov Identifier: | NCT00359021 |
| Other Study ID Numbers: |
CR002740 TMC125-C217 ( Other Identifier: Tibotec Pharmaceuticals ) TMC125-C206 ( Other Identifier: Tibotec Pharmaceuticals ) TMC125-C216 ( Other Identifier: Tibotec Pharmaceuticals ) |
| First Submitted: | July 28, 2006 |
| First Posted: | August 1, 2006 |
| Results First Submitted: | January 29, 2013 |
| Results First Posted: | March 7, 2013 |
| Last Update Posted: | May 16, 2014 |