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
Fort Collins, Colorado 80528
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Fort Collins, CO
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Akron, Ohio 44313
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Akron, OH
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Atlanta, Georgia 30341
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Atlanta, GA
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Beverly Hills, California 90211
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Beverly Hills, CA
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Brooklyn, New York 11215
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Brooklyn, NY
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Charlotte, North Carolina 28203
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Charlotte, NC
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Columbia, South Carolina 29203
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Columbia, SC
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Dallas, Texas 75230
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Dallas, TX
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Denver, Colorado 80206
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Denver, CO
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Detroit, Michigan 48202
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Detroit, MI
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Fort Lauderdale, Florida 33308
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Fort Lauderdale, FL
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Fort Myers, Florida 33916
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Fort Myers, FL
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Fort Worth, Texas 76104
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Fort Worth, TX
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Fresno, California 93720
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Fresno, CA
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Hampton, Virginia 23666
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Hampton, VA
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Hillsborough, New Jersey 08844
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Hillsborough, NJ
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Hollywood, Florida 33021
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Hollywood, FL
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Houston, Texas 77030
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Houston, TX
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Jackson, Mississippi 39202
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Jackson, MS
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Jacksonville, Florida 32207
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Jacksonville, FL
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Laguna Beach, California 90803
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Laguna Beach, CA
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Lexington, Kentucky 40504
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Lexington, KY
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Long Beach, California 90813
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Long Beach, CA
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Longview, Texas 75605
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Longview, TX
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Louisville, Kentucky 40202
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Louisville, KY
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Miami, Florida 33136
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Miami, FL
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New Orleans, Louisiana 70112
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New Orleans, LA
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New York, New York 10032
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New York, NY
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Orlando, Florida 32806
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Orlando, FL
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Plantation, Florida 33324
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Plantation, FL
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Ponce,
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Rochester, New York 14642
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Rochester, NY
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Shreveport, Louisiana 71103
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Shreveport, LA
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Somers Point, New Jersey 08244
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Somers Point, NJ
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Tampa, Florida 33612
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Tampa, FL
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Tarzana, California 91356
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Tarzana, CA
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Tulsa, Oklahoma 74105
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Tulsa, OK
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Valhalla, New York 10595
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Valhalla, NY
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Washington, D.C., District of Columbia 20007
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Washington, D.C.,
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West Palm Beach, Florida 33409
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West Palm Beach, FL
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