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Infection, Human Immunodeficiency Virus IPhase 3NCT00094523

Fosamprenavir Versus Other Protease Inhibitors

A Phase 3 study testing Fosamprenavir in people with Infection, Human Immunodeficiency Virus I, run by ViiV Healthcare at 52 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Fosamprenavir
Could I receive a placebo?
No, everyone receives an active treatment
How many people
314 participants
Where
52 sitesin 2 countries
Study dates
14 Dec 2004to 29 Jun 2007
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

52 sites in 2 countries.

52 sites in 2 countries

United States51 sites

  • GSK Investigational Site

    Akron, Ohio, 44304

  • GSK Investigational Site

    Allentown, Pennsylvania, 18103

  • GSK Investigational Site

    Atlanta, Georgia, 30339

  • GSK Investigational Site

    Augusta, Georgia, 30912

  • GSK Investigational Site

    Beverly Hills, California, 90210

  • GSK Investigational Site

    Brooklyn, New York, 11212

  • GSK Investigational Site

    Charlotte, North Carolina, 28209

  • GSK Investigational Site

    Charlotte, North Carolina, 28211

  • GSK Investigational Site

    Columbia, South Carolina, 29206-4713

  • GSK Investigational Site

    Dallas, Texas, 75208

  • GSK Investigational Site

    Dallas, Texas, 75246

  • GSK Investigational Site

    Denver, Colorado, 80220

  • GSK Investigational Site

    Des Moines, Iowa, 50309-1426

  • GSK Investigational Site

    Detroit, Michigan, 48202

  • GSK Investigational Site

    Fort Collins, Colorado, 80528

  • GSK Investigational Site

    Fort Lauderdale, Florida, 33145

  • GSK Investigational Site

    Fort Lauderdale, Florida, 33306

  • GSK Investigational Site

    Fort Lauderdale, Florida, 33308

  • GSK Investigational Site

    Fort Myers, Florida, 33901

  • GSK Investigational Site

    Fort Worth, Texas, 76104

  • GSK Investigational Site

    Fresno, California, 93720

  • GSK Investigational Site

    Hampton, Virginia, 23666

  • GSK Investigational Site

    Hillsborough, New Jersey, 08844

  • GSK Investigational Site

    Houston, Texas, 77027

  • GSK Investigational Site

    Houston, Texas, 77098

  • GSK Investigational Site

    Jackson, Mississippi, 39202

  • GSK Investigational Site

    Jacksonville, Florida, 32206

  • GSK Investigational Site

    Laguna Beach, California, 90803

  • GSK Investigational Site

    Lexington, Kentucky, 40536

  • GSK Investigational Site

    Long Beach, California, 90813

  • GSK Investigational Site

    Longview, Texas, 75604

  • GSK Investigational Site

    Los Angeles, California, 90069

  • GSK Investigational Site

    Louisville, Kentucky, 40202

  • GSK Investigational Site

    Miami, Florida, 33136

  • GSK Investigational Site

    Morristown, Tennessee, 37813

  • GSK Investigational Site

    New Orleans, Louisiana, 70115

  • GSK Investigational Site

    New Orleans, Louisiana, 70121

  • GSK Investigational Site

    New York, New York, 10014

  • GSK Investigational Site

    Oklahoma City, Oklahoma, 73104

  • GSK Investigational Site

    Orlando, Florida, 32804

  • GSK Investigational Site

    Plantation, Florida, 33317

  • GSK Investigational Site

    Rochester, New York, 14604

  • GSK Investigational Site

    Shreveport, Louisiana, 71103

  • GSK Investigational Site

    Somers Point, New Jersey, 08244

  • GSK Investigational Site

    Tampa, Florida, 33614

  • GSK Investigational Site

    Tarzana, California, 91356

  • GSK Investigational Site

    Tulsa, Oklahoma, 74129

  • GSK Investigational Site

    Valhalla, New York, 10595

  • GSK Investigational Site

    Washington D.C., District of Columbia, 20037

  • GSK Investigational Site

    West Palm Beach, Florida, 33408

  • GSK Investigational Site

    Wichita, Kansas, 67214

Other trials in United States

Puerto Rico1 site

  • GSK Investigational Site

    Ponce, 731

Other trials in Puerto Rico

About this study

Official title: 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.

Being tested
Fosamprenavir
Keywords
fosamprenavir LEXIVA non-inferiority safety tolerability
Medical subject headings
Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FosamprenavirDrug

    Fosamprenavir

Study groups in NCT00094523
Study groupRoleWhat they receive
Treatment Arm AExperimentalSubjects switched their baseline PI for fosamprenavir (± ritonavir) while maintaining their baseline regimen of two nucleoside or nucleotide reverse transcriptase inhibitors for 48 weeks.
Receives: Drug: Fosamprenavir
Treatment Arm BExperimentalSubjects 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
Receives: Drug: Fosamprenavir

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of subjects with HIV-1 RNA less than 400 copies/mL

    Measured: Week 24

Secondary outcomes (20)

  1. Percentage of subjects with plasma HIV-1 RNA <400 copies/mL

    Measured: Week 48

  2. Percentage of subjects with plasma HIV-1 RNA <50 copies/mL at Week 24

    Measured: Week 24

  3. Percentage of subjects with plasma HIV-1 RNA <50 copies/mL at Week 48

    Measured: Week 48

  4. Number of subjects with any adverse events (AEs)

    Measured: up to Week 48

  5. Number of subjects with gastrointestinal (GI) AEs

    Measured: up to Week 48

  6. Absolute values of plasma HIV-1 RNA at Week 24

    Measured: Week 24

  7. Median change from Baseline in HIV-1 RNA at Week 24

    Measured: Baseline and Week 24

  8. Absolute values of plasma HIV-1 RNA at Week 48

    Measured: Week 48

  9. Median change from Baseline in HIV-1 RNA at Week 48

    Measured: Baseline and Week 48

  10. Absolute values in Cluster of Differentiation 4+ (CD4+) Cell Counts at Week 24

    Measured: Week 24

  11. Absolute values in Cluster of Differentiation 4+ (CD4+) Cell Counts at Week 48

    Measured: Week 48

  12. Median change from Baseline in Cluster of Differentiation 4+ (CD4+) Cell Counts at Week 24

    Measured: Baseline and Week 24

  13. Median change from Baseline in Cluster of Differentiation 4+ (CD4+) Cell Counts at Week 48

    Measured: Baseline and Week 48

  14. Number of subjects with genotypic resistance at virologic failure

    Measured: up to Week 48

  15. Number of subjects with phenotypic resistance at virologic failure

    Measured: up to Week 48

  16. Time to loss of virologic response (TLOVR)

    Measured: up to Week 48

  17. Medication adherence at Week 24

    Measured: Week 24

  18. Medication adherence at Week 48

    Measured: Week 48

  19. Subject treatment satisfaction per the HIV Treatment Satisfaction Questionnaire at Week 24

    Measured: Week 24

  20. Subject treatment satisfaction per the HIV Treatment Satisfaction Questionnaire at Week 48

    Measured: Week 48

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Oct 2004 (estimated)
  2. Study start14 Dec 2004
  3. Primary completion29 Jun 2007
  4. Study completion29 Jun 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
314 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00094523
Sponsor's protocol ID
100290
Status last verified
Apr 2018
First submitted
20 Oct 2004
Last updated
18 Apr 2018
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Fosamprenavir in people with Infection, Human Immunodeficiency Virus I, run by ViiV Healthcare at 52 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 52 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of subjects with HIV-1 RNA less than 400 copies/mL (time frame: Week 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00094523.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2018.

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