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Fosamprenavir Versus Other Protease Inhibitors

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ClinicalTrials.gov Identifier: NCT00094523
Recruitment Status : Completed
First Posted : October 21, 2004
Last Update Posted : April 18, 2018
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
ViiV Healthcare

Brief 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.

Condition or disease Intervention/treatment Phase
Infection, Human Immunodeficiency Virus I Drug: Fosamprenavir Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 314 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : December 14, 2004
Actual Primary Completion Date : June 29, 2007
Actual Study Completion Date : June 29, 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Percentage of subjects with HIV-1 RNA less than 400 copies/mL [ Time Frame: Week 24 ]

Secondary Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00094523


  Show 52 Study Locations
Sponsors and Collaborators
ViiV Healthcare
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials ViiV Healthcare

Responsible Party: ViiV Healthcare
ClinicalTrials.gov Identifier: NCT00094523     History of Changes
Other Study ID Numbers: 100290
First Posted: October 21, 2004    Key Record Dates
Last Update Posted: April 18, 2018
Last Verified: April 2018

Keywords provided by ViiV Healthcare:
fosamprenavir LEXIVA non-inferiority safety tolerability

Additional relevant MeSH terms:
Immunologic Deficiency Syndromes
Acquired Immunodeficiency Syndrome
HIV Infections
Immune System Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Protease Inhibitors
Fosamprenavir
HIV Protease Inhibitors
Reverse Transcriptase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Nucleic Acid Synthesis Inhibitors