A Study of an Investigational Regimen Combining FDA Approved HIV Drugs in HIV-Infected Subjects
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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: NCT00363142 |
Recruitment Status :
Completed
First Posted : August 15, 2006
Results First Posted : September 24, 2009
Last Update Posted : November 5, 2010
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Sponsor:
GlaxoSmithKline
Information provided by:
GlaxoSmithKline
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
Conditions |
HIV Infection Infection, Human Immunodeficiency Virus |
Interventions |
Drug: Half-boosted Fosamprenavir Drug: Full Boosted Fosamprenavir |
Enrollment | 211 |
Participant Flow
Recruitment Details | |
Pre-assignment Details | Participants were stratified prior to randomization according to baseline regimen (700 milligrams [mg]/100 mg twice a day [BID] or 1400 mg/200 mg once a day [QD]) and previous regimen (no other prior protease inhibitor [PI], non-boosted PI, or boosted PI). Results are reported for the 209 participants (out of 211 enrolled) receiving study drug. |
Arm/Group Title | FPV/r100 | FPV/r200 |
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Fosamprenavir (FPV)/ritonavir (RTV) 1400mg/100mg once a day (QD) | FPV/RTV (either 700mg/100mg twice a day [BID] or 1400mg/200mg QD) |
Period Title: Overall Study | ||
Started | 140 | 69 |
Completed | 133 | 66 |
Not Completed | 7 | 3 |
Reason Not Completed | ||
Adverse Event | 2 | 0 |
Lack of Efficacy | 0 | 1 |
Lost to Follow-up | 1 | 0 |
Non-compliance | 1 | 1 |
Withdrawal by Subject | 3 | 1 |
Baseline Characteristics
Arm/Group Title | FPV/r100 | FPV/r200 | Total | |
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Fosamprenavir (FPV)/ritonavir (RTV) 1400mg/100mg once a day (QD) | FPV/RTV (either 700mg/100mg twice a day [BID] or 1400mg/200mg QD) | Total of all reporting groups | |
Overall Number of Baseline Participants | 140 | 69 | 209 | |
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[Not Specified]
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Age Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 140 participants | 69 participants | 209 participants | |
44.9 (10.52) | 44.3 (8.9) | 44.7 (10.00) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 140 participants | 69 participants | 209 participants | |
Female |
33 23.6%
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9 13.0%
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42 20.1%
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Male |
107 76.4%
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60 87.0%
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167 79.9%
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Race/Ethnicity, Customized
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 140 participants | 69 participants | 209 participants |
African American/African heritage | 42 | 20 | 62 | |
American Indian/Alaskan native | 1 | 0 | 1 | |
Asian - South East Asian | 0 | 2 | 2 | |
Native Hawaiian or Other Pacific Islander | 0 | 1 | 1 | |
White - Arabic/North African | 0 | 2 | 2 | |
White - White/Caucasian/European | 95 | 44 | 139 | |
Mixed race | 1 | 0 | 1 | |
Other | 1 | 0 | 1 | |
Ethnicity (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 140 participants | 69 participants | 209 participants | |
Hispanic or Latino |
31 22.1%
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11 15.9%
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42 20.1%
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Not Hispanic or Latino |
109 77.9%
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58 84.1%
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167 79.9%
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Unknown or Not Reported |
0 0.0%
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0 0.0%
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0 0.0%
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Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
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.
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
Name/Title: | GSK Response Center |
Organization: | GlaxoSmithKline |
Phone: | 866-435-7343 |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | E.D. Derilus; Clinical Disclosure Advisor, GSK Clinical Disclosure |
ClinicalTrials.gov Identifier: | NCT00363142 |
Other Study ID Numbers: |
LEX106430 |
First Submitted: | August 11, 2006 |
First Posted: | August 15, 2006 |
Results First Submitted: | June 11, 2009 |
Results First Posted: | September 24, 2009 |
Last Update Posted: | November 5, 2010 |