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

Study Type:	Interventional
Study Design:	Non-Randomized, Open Label, Single Group Assignment
Condition:	HIV
Intervention:	Drug: TMC125, Darunavir; Ritonavir

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
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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Serious Adverse Events

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Other Adverse Events

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Time Frame	No text entered.
Additional Description	No text entered.

Frequency Threshold

Threshold above which other adverse events are reported	0%

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.

Other Adverse Events

	Darunavir(TMC114)/Eravirine(TMC125)
Total, other (not including serious) adverse events
# participants affected / at risk	10
Gastrointestinal disorders
Constipation * ^A # participants affected / at risk # events	1/10 (10.00%) 1
Diarrhea * ^B # participants affected / at risk # events	3/10 (30.00%) 3
Dry mouth * ^C # participants affected / at risk # events	1/10 (10.00%) 1
Nausea * ^A # participants affected / at risk # events	1/10 (10.00%) 1
General disorders
Abdominal pain upper * ^A # participants affected / at risk # events	1/10 (10.00%) 1
Fatigue * ^B # participants affected / at risk # events	4/10 (40.00%) 4
Pain * ^A # participants affected / at risk # events	1/10 (10.00%) 1
Infections and infestations
Diverticulitis * ^A # participants affected / at risk # events	1/10 (10.00%) 1
Metabolism and nutrition disorders
Decreased appetite * ^A # participants affected / at risk # events	1/10 (10.00%) 1
Hypercholesterolaemia * ^A # participants affected / at risk # events	1/10 (10.00%) 1
Nervous system disorders
Amnesia * ^A # participants affected / at risk # events	1/10 (10.00%) 1
Disturbance in attention * ^A # participants affected / at risk # events	1/10 (10.00%) 1
Dizziness * ^A # participants affected / at risk # events	1/10 (10.00%) 1
Headache * ^B # participants affected / at risk # events	3/10 (30.00%) 3
Somnolence * ^A # participants affected / at risk # events	1/10 (10.00%) 1
Psychiatric disorders
Depression * ^B # participants affected / at risk # events	2/10 (20.00%) 2
Insomnia * ^B # participants affected / at risk # events	2/10 (20.00%) 2
Skin and subcutaneous tissue disorders
Dermatitis * ^A # participants affected / at risk # events	1/10 (10.00%) 1
Rash * ^B # participants affected / at risk # events	3/10 (30.00%) 3
Vascular disorders
Heart rate increase * ^A # participants affected / at risk # events	1/10 (10.00%) 1
Hypertension * ^B # participants affected / at risk # events	2/10 (20.00%) 2

*	Indicates events were collected by non-systematic assessment.
^A	Term from vocabulary, MedDRA (10.0)
^B	Term from vocabulary, MedDRA 10.0
^C	Term from vocabulary, MesDRA 10.0

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.

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

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

No publications provided

Responsible Party:	Tibotec Therapeutics Clinical Affairs, a Division of Centocor Ortho Biotech Services, LLC. ( Vice President Clinical Affairs )
Study ID Numbers:	CR011866, TMC114HIV3009
Study First Received:	April 13, 2007
Results First Received:	October 2, 2009
Last Updated:	October 2, 2009
ClinicalTrials.gov Identifier:	NCT00460746 History of Changes
Health Authority:	United States: Food and Drug Administration