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

This study has been completed.

Study NCT00460746 Information provided by Tibotec, Inc

First Received: April 13, 2007 Last Updated: October 2, 2009 History of Changes

Study Type:	Interventional
Study Design:	Non-Randomized, Open Label, Single Group Assignment
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 potease inhibitor(s) (PIs), non-nucleoside reverse transriptase inhibitor(s) (NNRTIs), and enfuviritide (ENF) were replaced by DRV/r and ETR in subjects with intolerence 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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Reporting Groups

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

Evaluation of the 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. [ 48 weeks ]

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2. Secondary:

Evaluation of the 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. [ 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 (Intent To Treat (ITT)-Last Observation Carried Forward (LOCF)). [ 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 (Intent To Treat (ITT)-Last Observation Carried Forward (LOCF)). [ Week 48 ]

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5. Secondary:

Median Change From Baseline in Triglycerides (LOCF). ITT Population. [ Week 48 ]

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6. Secondary:

Median Change From Baseline in Total Cholesterol(LOCF). ITT Population. [ Week 48 ]

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7. Secondary:

Median Change From Baseline in LDL Cholesterol (LOCF). ITT Population. [ Week 48 ]

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8. Secondary:

Median Change From Baseline in HDL Cholesterol (LOCF). ITT Population. [ Week 48 ]

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9. Secondary:

Median Change From Baseline in TC/HDL Ratio (LOCF). ITT Population. [ Week 48 ]

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10. Secondary:

Median Change From Baseline in Glucose (LOCF). ITT Population. [ Week 48 ]

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