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Fosamprenavir Versus Other Protease Inhibitors

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00094523
First received: October 20, 2004
Last updated: March 17, 2011
Last verified: March 2011

October 20, 2004
March 17, 2011
December 2004
Not Provided
Proportion of subjects with HIV-1 RNA less than 400 copies/mL [ Time Frame: 24 weeks ]
Not Provided
Complete list of historical versions of study NCT00094523 on ClinicalTrials.gov Archive Site
  • % subjects with HIV-1 RNA <400 copies/mL [ Time Frame: week 48 ]
  • % subjects with HIV-1 RNA <50 copies/mL AEs CD4 and HIV-1 RNA [ Time Frame: weeks 24 and 48 ]
  • Adherence to study medications [ Time Frame: Throughout study ]
Not Provided
Not Provided
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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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Human Immunodeficiency Virus I Infection
  • HIV Infection
Drug: fosamprenavir
Other Name: fosamprenavir
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
312
June 2007
Not Provided

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Puerto Rico
 
NCT00094523
100290
No
Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials, PharmD GlaxoSmithKline
GlaxoSmithKline
March 2011

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