Enfuvirtide/Current Protease Inhibitor Switch to PREZISTA (Darunavir)/Ritonavir + TMC125 in HIV Patients With Enfuvirtide Side Effects.

This study has been completed.

Sponsor:

Collaborator:

Tibotec Therapeutics, a Division of Ortho Biotech Products, L.P., USA

Information provided by (Responsible Party):

Tibotec, Inc

ClinicalTrials.gov Identifier:

NCT00460746

First received: April 13, 2007

Last updated: July 24, 2013

Last verified: July 2013

History of Changes

Results First Received: October 2, 2009

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

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
Darunavir(TMC114)/Eravirine(TMC125)	Darunavir/ritonavir (DRV/r) combined with Etravirine ([ETR] also known as TMC125) when current protease inhibitor(s) (PIs), non-nucleoside reverse transriptase inhibitor(s) (NNRTIs), and enfuviritide (ENF) were replaced by DRV/r and ETR in subjects with intolerance to ENF.

Participant Flow: Overall Study

	Darunavir(TMC114)/Eravirine(TMC125)
STARTED	10
COMPLETED	8
NOT COMPLETED	2
Adverse Event	1
Lost to Follow-up	1

Baseline Characteristics

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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.
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Reporting Groups

	Description
Darunavir(TMC114)/Eravirine(TMC125)	Darunavir/ritonavir (DRV/r) combined with Etravirine ([ETR] also known as TMC125) when current protease inhibitor(s) (PIs), non-nucleoside reverse transriptase inhibitor(s) (NNRTIs), and enfuviritide (ENF) were replaced by DRV/r and ETR in subjects with intolerance to ENF.

Baseline Measures

	Darunavir(TMC114)/Eravirine(TMC125)
Number of Participants [units: participants]	10
Age [units: years] Median (Full Range)	48 (35 to 61)
Gender [units: participants]
Female	0
Male	10
Race/Ethnicity, Customized [units: participants]
White	6
Hispanic	4
Viral Load <50 copies/mL [units: participants]	10
CD4 count [units: cells/mm^3] Median (Full Range)	301 (187 to 663)

Outcome Measures

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1. Primary:

Proportion of Patients Who Maintain Plasma HIV Viral Load Measurements < 400 Copies/ml at 2, 4, 8, 12, 16, 24, 36 and 48 Weeks After Switching to DRV/r and ETR, Missing Equals Failure. [ Time Frame: 48 weeks ]

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2. Secondary:

Proportion of Patients Who Have Viral Load Measurements <50 Copies/ml at 2, 4, 8, 12, 16, 24, 36 and 48 Weeks After Switching to DRV/r and ETR, Missing Equals Failure. [ Time Frame: 48 weeks ]

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3. Secondary:

CD4+ Cell Count (x 10^6 Cell/L): Baseline and Median Changes From Baseline at 4, 8, 12, 16, 24, 36 and 48 Weeks. [ Time Frame: Week 48 ]

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4. Secondary:

CD4+ Cell Count (x 10^6 Cell/L): Baseline and Mean Changes From Baseline at 4, 8, 12, 16, 24,36 and 48 Weeks. [ Time Frame: Week 48 ]

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5. Secondary:

Median Change From Baseline in Triglycerides at Week 48. [ Time Frame: Week 48 ]

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6. Secondary:

Median Change From Baseline in Total Cholesterol at Week 48. [ Time Frame: Week 48 ]

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7. Secondary:

Median Change From Baseline in LDL Cholesterol at Week 48. [ Time Frame: Week 48 ]

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8. Secondary:

Median Change From Baseline in HDL Cholesterol. [ Time Frame: Week 48 ]

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9. Secondary:

Median Change From Baseline in Total Cholesterol (TC) / High Denisty Lipoprotein (HDL) Ratio at Week 48. [ Time Frame: Week 48 ]

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10. Secondary:

Median Change From Baseline in Glucose at Week 48. [ Time Frame: Week 48 ]

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Serious Adverse Events

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Other Adverse Events

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Limitations and Caveats

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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
Conclusions on efficacy and safety are limited as the target enrollment of 40 subjects was not reached due to a shortage of eligible subjects.

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: If TTCA does not publish within 12 months after study conclusion or after TTCA confirms there will be no multicenter publication, Institution may publish their results from their site individually, provided TTCA has 60 day review for confidentiality and additional 60 day delay for patent application.

Results Point of Contact:

Name/Title: Vice President, Tibotec Therapeutics Clinical Affairs
Organization: Tibotec Therapeutics Clinical Affairs, Division of Centocor Ortho Biotech Services, LLC
phone: 877-732-2488
e-mail: rfalcon@its.jnj.com

Responsible Party:	Tibotec, Inc
ClinicalTrials.gov Identifier:	NCT00460746 History of Changes
Other Study ID Numbers:	CR011866 TMC114HIV3009 ( Other Identifier: Tibotec, Inc. )
Study First Received:	April 13, 2007
Results First Received:	October 2, 2009
Last Updated:	July 24, 2013
Health Authority:	United States: Food and Drug Administration

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