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

This study has been completed.

Sponsor:

Information provided by:

Tibotec Pharmaceuticals, Ireland

ClinicalTrials.gov Identifier:

NCT00540449

First received: October 4, 2007

Last updated: October 25, 2012

Last verified: October 2012

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

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

Reporting Groups

	Description
TMC278	25 mg tablet once daily for 96 weeks
Efavirenz	600mg once daily for 96 weeks
Total	Total of all reporting groups

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

1. Primary:

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

Show Outcome Measure 1

2. Secondary:

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

Show Outcome Measure 2

Serious Adverse Events

Other Adverse Events

More Information