Fosamprenavir Versus Other Protease Inhibitors

April 16, 2018 updated by: ViiV Healthcare

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
314

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Puerto Rico
      • Ponce, Puerto Rico, 731
        • GSK Investigational Site
  • United States
    • California
      • Beverly Hills, California, United States, 90210
        • GSK Investigational Site
      • Fresno, California, United States, 93720
        • GSK Investigational Site
      • Laguna Beach, California, United States, 90803
        • GSK Investigational Site
      • Long Beach, California, United States, 90813
        • GSK Investigational Site
      • Los Angeles, California, United States, 90069
        • GSK Investigational Site
      • Tarzana, California, United States, 91356
        • GSK Investigational Site
    • Colorado
      • Denver, Colorado, United States, 80220
        • GSK Investigational Site
      • Fort Collins, Colorado, United States, 80528
        • GSK Investigational Site
    • District of Columbia
      • Washington, District of Columbia, United States, 20037
        • GSK Investigational Site
    • Florida
      • Fort Lauderdale, Florida, United States, 33306
        • GSK Investigational Site
      • Fort Lauderdale, Florida, United States, 33308
        • GSK Investigational Site
      • Fort Lauderdale, Florida, United States, 33145
        • GSK Investigational Site
      • Fort Myers, Florida, United States, 33901
        • GSK Investigational Site
      • Jacksonville, Florida, United States, 32206
        • GSK Investigational Site
      • Miami, Florida, United States, 33136
        • GSK Investigational Site
      • Orlando, Florida, United States, 32804
        • GSK Investigational Site
      • Plantation, Florida, United States, 33317
        • GSK Investigational Site
      • Tampa, Florida, United States, 33614
        • GSK Investigational Site
      • West Palm Beach, Florida, United States, 33408
        • GSK Investigational Site
    • Georgia
      • Atlanta, Georgia, United States, 30339
        • GSK Investigational Site
      • Augusta, Georgia, United States, 30912
        • GSK Investigational Site
    • Iowa
      • Des Moines, Iowa, United States, 50309-1426
        • GSK Investigational Site
    • Kansas
      • Wichita, Kansas, United States, 67214
        • GSK Investigational Site
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • GSK Investigational Site
      • Louisville, Kentucky, United States, 40202
        • GSK Investigational Site
    • Louisiana
      • New Orleans, Louisiana, United States, 70115
        • GSK Investigational Site
      • New Orleans, Louisiana, United States, 70121
        • GSK Investigational Site
      • Shreveport, Louisiana, United States, 71103
        • GSK Investigational Site
    • Michigan
      • Detroit, Michigan, United States, 48202
        • GSK Investigational Site
    • Mississippi
      • Jackson, Mississippi, United States, 39202
        • GSK Investigational Site
    • New Jersey
      • Hillsborough, New Jersey, United States, 08844
        • GSK Investigational Site
      • Somers Point, New Jersey, United States, 08244
        • GSK Investigational Site
    • New York
      • Brooklyn, New York, United States, 11212
        • GSK Investigational Site
      • New York, New York, United States, 10014
        • GSK Investigational Site
      • Rochester, New York, United States, 14604
        • GSK Investigational Site
      • Valhalla, New York, United States, 10595
        • GSK Investigational Site
    • North Carolina
      • Charlotte, North Carolina, United States, 28209
        • GSK Investigational Site
      • Charlotte, North Carolina, United States, 28211
        • GSK Investigational Site
    • Ohio
      • Akron, Ohio, United States, 44304
        • GSK Investigational Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • GSK Investigational Site
      • Tulsa, Oklahoma, United States, 74129
        • GSK Investigational Site
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18103
        • GSK Investigational Site
    • South Carolina
      • Columbia, South Carolina, United States, 29206-4713
        • GSK Investigational Site
    • Tennessee
      • Morristown, Tennessee, United States, 37813
        • GSK Investigational Site
    • Texas
      • Dallas, Texas, United States, 75246
        • GSK Investigational Site
      • Dallas, Texas, United States, 75208
        • GSK Investigational Site
      • Fort Worth, Texas, United States, 76104
        • GSK Investigational Site
      • Houston, Texas, United States, 77027
        • GSK Investigational Site
      • Houston, Texas, United States, 77098
        • GSK Investigational Site
      • Longview, Texas, United States, 75604
        • GSK Investigational Site
    • Virginia
      • Hampton, Virginia, United States, 23666
        • GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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.
Drug: Fosamprenavir
Fosamprenavir
Experimental: 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
Drug: Fosamprenavir
Fosamprenavir

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Percentage of subjects with HIV-1 RNA less than 400 copies/mL
Time Frame: Week 24
Week 24

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Percentage of subjects with plasma HIV-1 RNA <400 copies/mL
Time Frame: Week 48
Week 48
Percentage of subjects with plasma HIV-1 RNA <50 copies/mL at Week 24
Time Frame: Week 24
Week 24
Percentage of subjects with plasma HIV-1 RNA <50 copies/mL at Week 48
Time Frame: Week 48
Week 48
Number of subjects with any adverse events (AEs)
Time Frame: up to Week 48
up to Week 48
Number of subjects with gastrointestinal (GI) AEs
Time Frame: up to Week 48
up to Week 48
Absolute values of plasma HIV-1 RNA at Week 24
Time Frame: Week 24
Week 24
Median change from Baseline in HIV-1 RNA at Week 24
Time Frame: Baseline and Week 24
Baseline and Week 24
Absolute values of plasma HIV-1 RNA at Week 48
Time Frame: Week 48
Week 48
Median change from Baseline in HIV-1 RNA at Week 48
Time Frame: Baseline and Week 48
Baseline and Week 48
Absolute values in Cluster of Differentiation 4+ (CD4+) Cell Counts at Week 24
Time Frame: Week 24
Week 24
Absolute values in Cluster of Differentiation 4+ (CD4+) Cell Counts at Week 48
Time Frame: Week 48
Week 48
Median change from Baseline in Cluster of Differentiation 4+ (CD4+) Cell Counts at Week 24
Time Frame: Baseline and Week 24
Baseline and Week 24
Median change from Baseline in Cluster of Differentiation 4+ (CD4+) Cell Counts at Week 48
Time Frame: Baseline and Week 48
Baseline and Week 48
Number of subjects with genotypic resistance at virologic failure
Time Frame: up to Week 48
up to Week 48
Number of subjects with phenotypic resistance at virologic failure
Time Frame: up to Week 48
up to Week 48
Time to loss of virologic response (TLOVR)
Time Frame: up to Week 48
up to Week 48
Medication adherence at Week 24
Time Frame: Week 24
Week 24
Medication adherence at Week 48
Time Frame: Week 48
Week 48
Subject treatment satisfaction per the HIV Treatment Satisfaction Questionnaire at Week 24
Time Frame: Week 24
Week 24
Subject treatment satisfaction per the HIV Treatment Satisfaction Questionnaire at Week 48
Time Frame: Week 48
Week 48

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
ViiV Healthcare

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
GlaxoSmithKline

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 14, 2004

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 29, 2007

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 29, 2007

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 20, 2004

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 20, 2004

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 21, 2004

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 18, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 16, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 100290

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings