Treatment Simplification by Darunavir/Ritonavir 800/100 mg Once a Day Versus a Triple Combination Therapy With Darunavir/Ritonavir (MONET)

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Janssen-Cilag International NV

ClinicalTrials.gov Identifier:

NCT00458302

First received: April 6, 2007

Last updated: December 14, 2012

Last verified: December 2012

History of Changes

Results First Received: February 4, 2010

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Treatment
Conditions:	HIV Infections AIDS Virus Human Immunodeficiency Virus Acquired Immunodeficiency Syndrome Virus
Intervention:	Drug: darunavir (DRV, TMC114)

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
DRV/r+2NRTIs	800 mg qd (2 x 400 mg tablet) + 2 NRTI for 144 weeks
DRV/r	800 mg qd (2 x 400 mg tablet) monotherapy for 144 weeks

Participant Flow: Overall Study

	DRV/r+2NRTIs	DRV/r
STARTED	129	127
COMPLETED	109	103
NOT COMPLETED	20	24
Adverse Event	4	14
Pregnancy	2	1
Protocol Violation	0	2
Withdrawal by Subject	6	4
Inc/Exc Criteria Not Met	1	1
Study Termination By Sponsor	1	0
Lost to Follow-up	2	0
Unknown	4	2

Baseline Characteristics

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Reporting Groups

	Description
DRV/r+2NRTIs	800 mg qd (2 x 400 mg tablet) + 2 NRTI for 144 weeks
DRV/r	800 mg qd (2 x 400 mg tablet) monotherapy for 144 weeks
Total	Total of all reporting groups

Baseline Measures

	DRV/r+2NRTIs	DRV/r	Total
Number of Participants [units: participants]	129	127	256
Age [units: participants]
<=18 years	0	0	0
Between 18 and 65 years	128	125	253
>=65 years	1	2	3
Age [units: years] Mean ± Standard Deviation	44.1 ± 9.74	43.4 ± 9.14	43.7 ± 9.43
Gender [units: participants]
Female	22	28	50
Male	107	99	206
Region of Enrollment [units: participants]
AUSTRIA	9	7	16
BELGIUM	12	12	24
DENMARK	14	14	28
GERMANY	14	14	28
HUNGARY	6	5	11
ISRAEL	1	7	8
ITALY	11	5	16
POLAND	9	20	29
PORTUGAL	7	7	14
RUSSIAN FEDERATION	9	2	11
SPAIN	24	24	48
SWITZERLAND	1	1	2
UNITED KINGDOM	12	9	21
plasma viral load ^[1] [units: participants]
< 50	125	118	243
50-400	4	7	11
400-1000	0	0	0
> 1000	0	2	2
CD4+ cell count (absolute count) [units: cells/µl] Median ( Full Range )	579.0 ( 163 to 1888 )	571.0 ( 162 to 1451 )	573.5 ( 162 to 1888 )

[1]	plasma viral load (HIV-1 RNA copies/ml)

Outcome Measures

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1. Primary:

Virological Response [Per Protocol (PP) - Time to Loss of Virologic Response (TLOVR), < 50 Copies/ml, Week 48] [ Time Frame: Week 48 ]

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2. Secondary:

Virological Response [Intent To Treat (ITT) - TLOVR, < 50 Copies/ml, Week 48] [ Time Frame: Week 48 ]

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3. Secondary:

Virological Response [Per Protocol (PP), TLOVR - Switch Equals Failure, < 50 Copies/ml, Week 144] [ Time Frame: Week 144 ]

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4. Secondary:

Virological Response [Intent To Treat (ITT), TLOVR - All Switches Included, < 50 Copies/ml, Week 144] [ Time Frame: Week 144 ]

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5. Secondary:

Virological Response [Per Protocol (PP), TLOVR - Switch Equals Failure, <200 Copies/ml, Week 144] [ Time Frame: week 144 ]

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6. Secondary:

Mean Change From Baseline in CD4+ Cell Count [ Time Frame: at week 4, 12, 24, 36, 48, 60, 72, 84, 96, 112, 128, 144 ]

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7. Secondary:

Resistance Determinations [ Time Frame: at each visit from baseline to week 144 ]

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8. Secondary:

Change From Baseline in Health-Related Quality of Life - FAHI Questionnaire Total Score [ Time Frame: at baseline, week 48, 96 and 144 ]

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Measure Type	Secondary
Measure Title	Change From Baseline in Health-Related Quality of Life - FAHI Questionnaire Total Score
Measure Description	The FAHI is a validated health-related quality of life questionnaire. The questionnaire consist of 44 items and includes 5 functional scales (physical, social, emotional, functional and global well-being and cognitive function). Each item is assessing the impact of HIV on a scale from 0 (not at all) to 5 (very much).
Time Frame	at baseline, week 48, 96 and 144
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
ITT: all randomised patients who had at least 1 dose of study medication, regardless of protocol adherence. A LOCF method was used for calculation.

Reporting Groups

	Description
DRV/r+2NRTIs	800 mg qd (2 x 400 mg tablet) + 2 NRTI for 144 weeks
DRV/r	800 mg qd (2 x 400 mg tablet) monotherapy for 144 weeks

Measured Values

	DRV/r+2NRTIs	DRV/r
Number of Participants Analyzed [units: participants]	126	112
Change From Baseline in Health-Related Quality of Life - FAHI Questionnaire Total Score [units: points on a scale] Mean ± Standard Error
week 48	1.7 ± 1.7	1.7 ± 2.0
week 96	0.4 ± 1.6	3.5 ± 2.4
week 144	0.7 ± 1.7	3.1 ± 2.4

No statistical analysis provided for Change From Baseline in Health-Related Quality of Life - FAHI Questionnaire Total Score

9. Secondary:

Change From Baseline in Health-Related Quality of Life - FAHI Questionnaire Cognitive Function Subscale [ Time Frame: at baseline, week 48, 96 and 144 ]

Show Outcome Measure 9

10. Secondary:

Change From Baseline in Health-Related Quality of Life - FAHI Questionnaire Emotional Well-Being Subscale [ Time Frame: at baseline, week 48, 96 and 144 ]

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11. Secondary:

Change From Baseline in Health-Related Quality of Life - FAHI Questionnaire Functional and Global Well-Being Subscale [ Time Frame: at baseline, week 48, 96 and 144 ]

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12. Secondary:

Change From Baseline in Health-Related Quality of Life - FAHI Questionnaire Physical Well-Being Subscale [ Time Frame: at baseline, week 48, 96 and 144 ]

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13. Secondary:

Change From Baseline in Health-Related Quality of Life - FAHI Questionnaire Social Well-Being Subscale [ Time Frame: at baseline, week 48, 96 and 144 ]

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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: Sponsor (SP) shall have the 1st right to present the Data without approval from the Principal Investigator (PI). If no publication is submitted by SP within 12 months after closure, or after SP confirms there will be no publication, the PI shall have the right to publish. Prior to submission, the PI will provide the SP with at least 45 days for review of a manuscript. If requested, the PI will withhold such publication for up to an additional 60 days to allow for filing of a patent application

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
This study was not blinded and not designed to demonstrate a safety benefit to stopping nucleoside analogues.

Results Point of Contact:

Name/Title: EMEA Medical Affairs Director Virology
Organization: Jan-Cilag Germany
phone: +49 7624 907580

No publications provided by Janssen-Cilag International NV

Publications automatically indexed to this study:

Arribas JR, Horban A, Gerstoft J, Fätkenheuer G, Nelson M, Clumeck N, Pulido F, Hill A, van Delft Y, Stark T, Moecklinghoff C. The MONET trial: darunavir/ritonavir with or without nucleoside analogues, for patients with HIV RNA below 50 copies/ml. AIDS. 2010 Jan 16;24(2):223-30.

Responsible Party:	Janssen-Cilag International NV
ClinicalTrials.gov Identifier:	NCT00458302 History of Changes
Other Study ID Numbers:	CR013159, TMC114HIV3006, 2006-006437-40
Study First Received:	April 6, 2007
Results First Received:	February 4, 2010
Last Updated:	December 14, 2012
Health Authority:	Belgium: Ministry of Social Affairs, Public Health and the Environment

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