TMC278-TiDP6-C209: A Clinical Trial in Treatment Naive HIV-1 Patients Comparing TMC278 to Efavirenz in Combination With Tenofovir + Emtricitabine.

This study is ongoing, but not recruiting participants.

Study NCT00540449 Information provided by Tibotec Pharmaceuticals, Ireland

First Received on October 4, 2007. Last Updated on December 7, 2011 History of Changes

Results First Received: June 14, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Conditions:	HIV Infections HIV-1 Human Immunodeficiency Virus Type 1
Interventions:	Drug: TMC278 Drug: efavirenz

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
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Reporting Groups

	Description
TMC278	25 mg tablet once daily for 96 weeks
Efavirenz	600mg once daily for 96 weeks

Participant Flow: Overall Study

	TMC278	Efavirenz
STARTED	346	344
COMPLETED	296 ^[1]	288 ^[1]
NOT COMPLETED	50	56
Adverse Event	8	28
Sponsor's Decision	2	1
Subject Ineligible To Continue The Trial	1	2
Lost to Follow-up	5	9
Subject Non-Compliant	6	2
Subject Reached A Virologic Endpoint	23	6
Withdrawal by Subject	4	7
Other	1	1

[1]	'Completed' represents the subjects that are ongoing at the time of cut-off for the WK48 analysis

Baseline Characteristics

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Reporting Groups

	Description
TMC278	25 mg tablet once daily for 96 weeks
Efavirenz	600mg once daily for 96 weeks

Baseline Measures

	TMC278	Efavirenz	Total
Number of Participants [units: participants]	346	344	690
Age [units: participants]
<=18 years	1	0	1
Between 18 and 65 years	343	343	686
>=65 years	2	1	3
Age [units: years] Mean ± Standard Deviation	37 ± 9.68	36.7 ± 9.51	36.8 ± 9.59
Gender [units: participants]
Female	78	69	147
Male	268	275	543
Region Enroll [units: participants]
Africa	32	31	63
Asia	47	51	98
Latin America	60	69	129
USA, Canada, Europe, Australia	207	193	400

Outcome Measures

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1. Primary:

Virological Response[ITT - TLOVR,<50 Copies/mL] [ Time Frame: Week 48 ]

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2. Secondary:

Virological Response[ITT - Snapshot,<50 Copies/mL] [ Time Frame: Week 48 ]

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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: No text entered.

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: Medical Leader
Organization: Tibotec
phone: 1 609 730 7561
e-mail: kboven@its.jnj.com

No publications provided by Tibotec Pharmaceuticals, Ireland

Publications automatically indexed to this study:

Molina JM, Cahn P, Grinsztejn B, Lazzarin A, Mills A, Saag M, Supparatpinyo K, Walmsley S, Crauwels H, Rimsky LT, Vanveggel S, Boven K; ECHO study group. Rilpivirine versus efavirenz with tenofovir and emtricitabine in treatment-naive adults infected with HIV-1 (ECHO): a phase 3 randomised double-blind active-controlled trial. Lancet. 2011 Jul 16;378(9787):238-46.

Responsible Party:	Compound Development Team Leader TMC278, Tibotec Pharmaceutical Limited
ClinicalTrials.gov Identifier:	NCT00540449 History of Changes
Obsolete Identifiers:	NCT00613639
Other Study ID Numbers:	CR002689, TMC278-TIDP6-C209
Study First Received:	October 4, 2007
Results First Received:	June 14, 2011
Last Updated:	December 7, 2011
Health Authority:	United States: Food and Drug Administration; Ireland: Irish Agriculture and Food Development Authority; Canada: Health Canada; Great Britain: Medicines and Healthcare Products Regulatory Agency; Taiwan: Department of Health