An Open-label Trial With TMC125 in Patients Who Have Virologically Failed in a DUET Trial (TMC125-C206 or TMC125-C216).

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Tibotec Pharmaceuticals, Ireland

ClinicalTrials.gov Identifier:

NCT00359021

First received: July 28, 2006

Last updated: March 13, 2013

Last verified: March 2013

History of Changes

Results First Received: January 29, 2013

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized; Endpoint Classification: Safety Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	HIV-1
Intervention:	Drug: TMC125

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups

	Description
DUET PLACEBO	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.
DUET TMC125	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.

Participant Flow: Overall Study

	DUET PLACEBO	DUET TMC125
STARTED	256	247
COMPLETED	175	195
NOT COMPLETED	81	52
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
Not specified	4	1
Pregnancy	1	0

Baseline Characteristics

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Reporting Groups

	Description
DUET PLACEBO	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.
DUET TMC125	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	Total of all reporting groups

Baseline Measures

	DUET PLACEBO	DUET TMC125	Total
Number of Participants [units: participants]	256	247	503
Age [units: participants]
<=18 years	0	0	0
Between 18 and 65 years	252	245	497
>=65 years	4	2	6
Age [units: years] Mean ± Standard Deviation	46.9 ± 8.28	46.6 ± 7.01	46.7 ± 7.68
Gender [units: participants]
Female	27	37	64
Male	229	210	439

Outcome Measures

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1. Primary:

The Number of Participants Experiencing Adverse Events [ Time Frame: 1 week to 180 weeks, with a median of 62 weeks ]

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2. Secondary:

The Percentage of Participants With Virologic Outcomes Over Time [ Time Frame: Weeks 24, 48, and 96 ]

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3. Secondary:

Change in Plasma Viral Load Versus Baseline (ie, Mean Change in log10 Plasma Viral Load From Baseline Over Time) [ Time Frame: Baseline, Week 24, Week 48, and Week 96 ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

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 agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: 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.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: SENIOR DIRECTOR R&D
Organization: Tibotec
phone: 1 609 730-7548

No publications provided

Responsible Party:	Tibotec Pharmaceuticals, Ireland
ClinicalTrials.gov Identifier:	NCT00359021 History of Changes
Other Study ID Numbers:	CR002740, TMC125-C217, TMC125-C206, TMC125-C216
Study First Received:	July 28, 2006
Results First Received:	January 29, 2013
Last Updated:	March 13, 2013
Health Authority:	United States: Food and Drug Administration Ireland: Irish Agriculture and Food Development Authority

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