Enfuvirtide/Current Protease Inhibitor Switch to PREZISTA (Darunavir)/Ritonavir + TMC125 in HIV Patients With Enfuvirtide Side Effects.
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00460746 |
Recruitment Status :
Completed
First Posted : April 16, 2007
Results First Posted : November 10, 2009
Last Update Posted : July 31, 2013
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Sponsor:
Tibotec, Inc
Collaborator:
Tibotec Therapeutics, a Division of Ortho Biotech Products, L.P., USA
Information provided by (Responsible Party):
Tibotec, Inc
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Study Type | Interventional |
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Study Design | Allocation: Non-Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
Condition |
HIV |
Intervention |
Drug: TMC125, Darunavir; Ritonavir |
Enrollment | 10 |
Participant Flow
Recruitment Details | |
Pre-assignment Details |
Arm/Group Title | Darunavir(TMC114)/Eravirine(TMC125) |
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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. |
Period Title: Overall Study | |
Started | 10 |
Completed | 8 |
Not Completed | 2 |
Reason Not Completed | |
Adverse Event | 1 |
Lost to Follow-up | 1 |
Baseline Characteristics
Arm/Group Title | Darunavir(TMC114)/Eravirine(TMC125) | |
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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. | |
Overall Number of Baseline Participants | 10 | |
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[Not Specified]
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Age Continuous
Median (Full Range) Unit of measure: Years |
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Number Analyzed | 10 participants | |
48
(35 to 61)
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 10 participants | |
Female |
0 0.0%
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Male |
10 100.0%
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Race/Ethnicity, Customized
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 10 participants |
White | 6 | |
Hispanic | 4 | |
Viral Load <50 copies/mL
Measure Type: Number Unit of measure: Participants |
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Number Analyzed | 10 participants | |
10 | ||
CD4 count
Median (Full Range) Unit of measure: Cells/mm^3 |
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Number Analyzed | 10 participants | |
301
(187 to 663)
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Outcome Measures
Adverse Events
Limitations and Caveats
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
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.
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 |
EMail: | rfalcon@its.jnj.com |
Responsible Party: | Tibotec, Inc |
ClinicalTrials.gov Identifier: | NCT00460746 |
Other Study ID Numbers: |
CR011866 TMC114HIV3009 ( Other Identifier: Tibotec, Inc. ) |
First Submitted: | April 13, 2007 |
First Posted: | April 16, 2007 |
Results First Submitted: | October 2, 2009 |
Results First Posted: | November 10, 2009 |
Last Update Posted: | July 31, 2013 |