Skip to main content
OpenTrials
Completed

NCT Number: NCT00094523

Fosamprenavir Versus Other Protease Inhibitors

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Infection, Human Immunodeficiency Virus I Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

GSK Investigational Site, Ponce, Puerto Rico

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

fosamprenavir

Drug

Fosamprenavir

Primary outcomes

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

    Time frame: Week 24

Secondary outcomes

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

    Time frame: Week 48

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

    Time frame: Week 24

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

    Time frame: Week 48

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

    Time frame: up to Week 48

  5. Number of subjects with gastrointestinal (GI) AEs

    Time frame: up to Week 48

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

    Time frame: Week 24

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

    Time frame: Baseline and Week 24

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

    Time frame: Week 48

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

    Time frame: Baseline and Week 48

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

    Time frame: Week 24

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

    Time frame: Week 48

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

    Time frame: Baseline and Week 24

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

    Time frame: Baseline and Week 48

  14. Number of subjects with genotypic resistance at virologic failure

    Time frame: up to Week 48

  15. Number of subjects with phenotypic resistance at virologic failure

    Time frame: up to Week 48

  16. Time to loss of virologic response (TLOVR)

    Time frame: up to Week 48

  17. Medication adherence at Week 24

    Time frame: Week 24

  18. Medication adherence at Week 48

    Time frame: Week 48

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

    Time frame: Week 24

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

    Time frame: Week 48

Sponsors and collaborators

Lead sponsor

ViiV Healthcare

Industry

Collaborators

  • GlaxoSmithKline

Registry information

Official study 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

Important dates

Study start
2004
Primary completion
2007
Study completion
2007
First posted
Oct 21, 2004
Registry last updated
Apr 18, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.