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Fosamprenavir Versus Other Protease Inhibitors

NCT ID: NCT00094523

Last Updated: 2018-04-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

314 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-12-14

Study Completion Date

2007-06-29

Brief Summary

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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.

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Detailed Description

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Conditions

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Infection, Human Immunodeficiency Virus I

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment Arm A

Subjects switched their baseline PI for fosamprenavir (± ritonavir) while maintaining their baseline regimen of two nucleoside or nucleotide reverse transcriptase inhibitors for 48 weeks.

Group Type EXPERIMENTAL

Fosamprenavir

Intervention Type DRUG

Fosamprenavir

Treatment Arm B

Subjects continued baseline regimen for first 24 weeks with the option of switching their initial PI for fosamprenavir (± ritonavir) while maintaining their baseline nucleoside or nucleotide reverse transcriptase inhibitor regimen for another 24 weeks

Group Type EXPERIMENTAL

Fosamprenavir

Intervention Type DRUG

Fosamprenavir

Interventions

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Fosamprenavir

Fosamprenavir

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role collaborator

ViiV Healthcare

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

ViiV Healthcare

Locations

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GSK Investigational Site

Beverly Hills, California, United States

Site Status

GSK Investigational Site

Fresno, California, United States

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GSK Investigational Site

Laguna Beach, California, United States

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GSK Investigational Site

Long Beach, California, United States

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GSK Investigational Site

Los Angeles, California, United States

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GSK Investigational Site

Tarzana, California, United States

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GSK Investigational Site

Denver, Colorado, United States

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GSK Investigational Site

Fort Collins, Colorado, United States

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GSK Investigational Site

Washington D.C., District of Columbia, United States

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GSK Investigational Site

Fort Lauderdale, Florida, United States

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GSK Investigational Site

Fort Lauderdale, Florida, United States

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GSK Investigational Site

Fort Lauderdale, Florida, United States

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GSK Investigational Site

Fort Myers, Florida, United States

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GSK Investigational Site

Jacksonville, Florida, United States

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Miami, Florida, United States

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Orlando, Florida, United States

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Plantation, Florida, United States

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Tampa, Florida, United States

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West Palm Beach, Florida, United States

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Atlanta, Georgia, United States

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Augusta, Georgia, United States

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GSK Investigational Site

Des Moines, Iowa, United States

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GSK Investigational Site

Wichita, Kansas, United States

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GSK Investigational Site

Lexington, Kentucky, United States

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GSK Investigational Site

Louisville, Kentucky, United States

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GSK Investigational Site

New Orleans, Louisiana, United States

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GSK Investigational Site

New Orleans, Louisiana, United States

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GSK Investigational Site

Shreveport, Louisiana, United States

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GSK Investigational Site

Detroit, Michigan, United States

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GSK Investigational Site

Jackson, Mississippi, United States

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GSK Investigational Site

Hillsborough, New Jersey, United States

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GSK Investigational Site

Somers Point, New Jersey, United States

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GSK Investigational Site

Brooklyn, New York, United States

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GSK Investigational Site

New York, New York, United States

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GSK Investigational Site

Rochester, New York, United States

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GSK Investigational Site

Valhalla, New York, United States

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GSK Investigational Site

Charlotte, North Carolina, United States

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GSK Investigational Site

Charlotte, North Carolina, United States

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GSK Investigational Site

Akron, Ohio, United States

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GSK Investigational Site

Oklahoma City, Oklahoma, United States

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GSK Investigational Site

Tulsa, Oklahoma, United States

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GSK Investigational Site

Allentown, Pennsylvania, United States

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GSK Investigational Site

Columbia, South Carolina, United States

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GSK Investigational Site

Morristown, Tennessee, United States

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GSK Investigational Site

Dallas, Texas, United States

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GSK Investigational Site

Dallas, Texas, United States

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GSK Investigational Site

Fort Worth, Texas, United States

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GSK Investigational Site

Houston, Texas, United States

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GSK Investigational Site

Houston, Texas, United States

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GSK Investigational Site

Longview, Texas, United States

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GSK Investigational Site

Hampton, Virginia, United States

Site Status

GSK Investigational Site

Ponce, , Puerto Rico

Site Status

Countries

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United States Puerto Rico

Other Identifiers

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100290

Identifier Type: -

Identifier Source: org_study_id

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