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Fosamprenavir Versus Other Protease Inhibitors | Clinical Trials | Clareo Health

COMPLETEDPHASE3

Fosamprenavir Versus Other Protease Inhibitors

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

NCT00094523•ViiV Healthcare

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.

Locations (52)

GSK Investigational Site

Beverly Hills, California, United States

GSK Investigational Site

Fresno, California, United States

GSK Investigational Site

Laguna Beach, California, United States

GSK Investigational Site

Long Beach, California, United States

GSK Investigational Site

Los Angeles, California, United States

GSK Investigational Site

Tarzana, California, United States

GSK Investigational Site

Denver, Colorado, United States

GSK Investigational Site

Fort Collins, Colorado, United States

GSK Investigational Site

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

GSK Investigational Site

Fort Lauderdale, Florida, United States

Key Dates

Start Date

December 14, 2004

Primary Completion Date

June 29, 2007

Completion Date

June 29, 2007

Last Updated

April 18, 2018

Enrollment

314

ACTUAL participants

Conditions

Infection, Human Immunodeficiency Virus I

Interventions

Fosamprenavir

DRUG

GW873140 In Combination With Combivir In HIV Infected Subjects

NCT00104429

Infection, Human Immunodeficiency Virus IHIV Infection

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COMPLETEDPHASE4

A Study Comparing The Safety, Tolerability and Efficacy of Trizivir VS Combivir & Atazanavir In Subjects With HIV

NCT00082394

Infection, Human Immunodeficiency Virus IHIV Infection

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 18, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Fosamprenavir Versus Other Protease Inhibitors

Inclusion Criteria

Exclusion Criteria

GW873140 In Combination With Combivir In HIV Infected Subjects

A Study Comparing The Safety, Tolerability and Efficacy of Trizivir VS Combivir & Atazanavir In Subjects With HIV

A Drug Interaction Study Evaluating Plasma GSK2248761 and GSK1349572 Pharmacokinetics in Healthy Adult Subjects.

Induction/Simplification With Atazanavir + Ritonavir + Abacavir/Lamivudine Fixed-Dose Combination In HIV-1 Infection