Fosamprenavir Versus Other Protease Inhibitors



Status:Completed
Conditions:Infectious Disease, HIV / AIDS, HIV / AIDS, HIV / AIDS
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - Any
Updated:6/10/2017
Start Date:December 2004
End Date:June 2007

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A Phase IIIB/IV, Open-label, Multi-center Trial to Evaluate the Safety, Tolerability, and Efficiency of HIV-1 Infected Subjects Switching Their Current Protease-inhibitor Therapies for a Fosamprenavir Therapy Over 48 Weeks

This study was designed to evaluate and compare safety, tolerability of subjects who
successfully suppress HIV-1 on their first PI regimen to those who switch to fosamprenavir.
This is a 48-week study, where subjects who were assigned to be in their original PI-group
have the option of switching to fosamprenavir on week 24. Prior to being assigned their
treatment group, subjects had to be suppressed for at least three months. All subjects also
take a background regimen of two nucleoside/nucleotide reverse transcriptase inhibitors.


Inclusion Criteria:

- Be on your first protease inhibitor (PI) containing regimen, and the regimen must
consist of a PI +/- ritonavir and 2 Nucleoside/Nucleotide Reverse Transcriptase
Inhibitors (N[t]RTIs).

- Have a plasma HIV-1 RNA level (viral load) at screening of less than 400 copies/mL,
for at least 3 months prior to Screening and at Screening while on your current
regimen of a PI +/- ritonavir + 2 N(t)RTIs.

- Females must not be pregnant or breastfeeding or plan to become pregnant during the
study.

- Females of child-bearing potential must agree to use one of the approved methods of
birth control.

Exclusion Criteria:

- Not able to follow the medication schedules and attend the study visits for the
entire length of the study.

- Have any other illnesses, laboratory test results, medication use, allergies, or
medical conditions that would make it unsafe for the subject to participate in this
study.

- Currently be enrolled in any other research studies that could affect the
subject''''s HIV-1 RNA levels.
We found this trial at
40
sites
Denver, Colorado 80206
407
mi
from
Denver, CO
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Akron, Ohio 44313
896
mi
from
Akron, OH
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Atlanta, Georgia 30341
801
mi
from
Atlanta, GA
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Beverly Hills, California 90211
1175
mi
from
Beverly Hills, CA
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Brooklyn, New York 11215
1288
mi
from
Brooklyn, NY
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Charlotte, North Carolina 28203
957
mi
from
Charlotte, NC
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Columbia, South Carolina 29203
969
mi
from
Columbia, SC
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Dallas, Texas 75230
340
mi
from
Dallas, TX
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Detroit, Michigan 48202
841
mi
from
Detroit, MI
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Fort Collins, Colorado 80528
428
mi
from
Fort Collins, CO
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Fort Lauderdale, Florida 33308
1306
mi
from
Fort Lauderdale, FL
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Fort Myers, Florida 33916
1207
mi
from
Fort Myers, FL
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Fort Worth, Texas 76104
348
mi
from
Fort Worth, TX
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Fresno, California 93720
1205
mi
from
Fresno, CA
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Hampton, Virginia 23666
1174
mi
from
Hampton, VA
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Hillsborough, New Jersey 08844
1252
mi
from
Hillsborough, NJ
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Hollywood, Florida 33021
1310
mi
from
Hollywood, FL
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Houston, Texas 77030
572
mi
from
Houston, TX
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Jackson, Mississippi 39202
572
mi
from
Jackson, MS
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Jacksonville, Florida 32207
1058
mi
from
Jacksonville, FL
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Laguna Beach, California 90803
1155
mi
from
Laguna Beach, CA
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Lexington, Kentucky 40504
723
mi
from
Lexington, KY
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Long Beach, California 90813
1172
mi
from
Long Beach, CA
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Longview, Texas 75605
402
mi
from
Longview, TX
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Louisville, Kentucky 40202
657
mi
from
Louisville, KY
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Miami, Florida 33136
1320
mi
from
Miami, FL
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New Orleans, Louisiana 70112
697
mi
from
New Orleans, LA
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New York, New York 10032
1290
mi
from
New York, NY
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Orlando, Florida 32806
1144
mi
from
Orlando, FL
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Plantation, Florida 33324
1302
mi
from
Plantation, FL
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?
mi
from
Ponce,
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Rochester, New York 14642
1121
mi
from
Rochester, NY
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Shreveport, Louisiana 71103
429
mi
from
Shreveport, LA
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Somers Point, New Jersey 08244
1256
mi
from
Somers Point, NJ
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Tampa, Florida 33612
1112
mi
from
Tampa, FL
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Tarzana, California 91356
1182
mi
from
Tarzana, CA
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Tulsa, Oklahoma 74105
152
mi
from
Tulsa, OK
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Valhalla, New York 10595
1299
mi
from
Valhalla, NY
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Washington, D.C., District of Columbia 20007
?
mi
from
Washington, D.C.,
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West Palm Beach, Florida 33409
1282
mi
from
West Palm Beach, FL
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