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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

October 20, 2004
October 21, 2004
April 18, 2018
December 14, 2004
June 29, 2007   (Final data collection date for primary outcome measure)
Percentage of subjects with HIV-1 RNA less than 400 copies/mL [ Time Frame: Week 24 ]
Not Provided
Complete list of historical versions of study NCT00094523 on ClinicalTrials.gov Archive Site
  • Percentage of subjects with plasma HIV-1 RNA <400 copies/mL [ Time Frame: Week 48 ]
  • Percentage of subjects with plasma HIV-1 RNA <50 copies/mL at Week 24 [ Time Frame: Week 24 ]
  • Percentage of subjects with plasma HIV-1 RNA <50 copies/mL at Week 48 [ Time Frame: Week 48 ]
  • Number of subjects with any adverse events (AEs) [ Time Frame: up to Week 48 ]
  • Number of subjects with gastrointestinal (GI) AEs [ Time Frame: up to Week 48 ]
  • Absolute values of plasma HIV-1 RNA at Week 24 [ Time Frame: Week 24 ]
  • Median change from Baseline in HIV-1 RNA at Week 24 [ Time Frame: Baseline and Week 24 ]
  • Absolute values of plasma HIV-1 RNA at Week 48 [ Time Frame: Week 48 ]
  • Median change from Baseline in HIV-1 RNA at Week 48 [ Time Frame: Baseline and Week 48 ]
  • Absolute values in Cluster of Differentiation 4+ (CD4+) Cell Counts at Week 24 [ Time Frame: Week 24 ]
  • Absolute values in Cluster of Differentiation 4+ (CD4+) Cell Counts at Week 48 [ Time Frame: Week 48 ]
  • Median change from Baseline in Cluster of Differentiation 4+ (CD4+) Cell Counts at Week 24 [ Time Frame: 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 ]
  • Number of subjects with genotypic resistance at virologic failure [ Time Frame: up to Week 48 ]
  • Number of subjects with phenotypic resistance at virologic failure [ Time Frame: up to Week 48 ]
  • Time to loss of virologic response (TLOVR) [ Time Frame: up to Week 48 ]
  • Medication adherence at Week 24 [ Time Frame: Week 24 ]
  • Medication adherence at Week 48 [ Time Frame: Week 48 ]
  • Subject treatment satisfaction per the HIV Treatment Satisfaction Questionnaire at Week 24 [ Time Frame: Week 24 ]
  • Subject treatment satisfaction per the HIV Treatment Satisfaction Questionnaire at Week 48 [ Time Frame: Week 48 ]
Not Provided
Not Provided
Not Provided
 
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
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Infection, Human Immunodeficiency Virus I
Drug: Fosamprenavir
Fosamprenavir
  • 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.
    Intervention: Drug: 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
    Intervention: Drug: Fosamprenavir
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
314
Not Provided
June 29, 2007
June 29, 2007   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Puerto Rico,   United States
 
 
NCT00094523
100290
No
Not Provided
Not Provided
ViiV Healthcare
ViiV Healthcare
GlaxoSmithKline
Study Director: GSK Clinical Trials ViiV Healthcare
ViiV Healthcare
April 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP