Clinical trial NCT00094523: Fosamprenavir Versus Other Protease Inhibitors
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Infection, Human Immunodeficiency Virus I
Keywords: fosamprenavir LEXIVA non-inferiority safety tolerability
Lead sponsor: ViiV Healthcare
Sponsor class: INDUSTRY
Collaborators: name: GlaxoSmithKline
First posted: 2004-10-21
Enrollment: 314
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Percentage of subjects with HIV-1 RNA less than 400 copies/mL
timeFrame: Week 24
Secondary outcomes:
measure: Percentage of subjects with plasma HIV-1 RNA <400 copies/mL
timeFrame: Week 48
measure: Percentage of subjects with plasma HIV-1 RNA <50 copies/mL at Week 24
timeFrame: Week 24
measure: Percentage of subjects with plasma HIV-1 RNA <50 copies/mL at Week 48
timeFrame: Week 48
measure: Number of subjects with any adverse events (AEs)
timeFrame: up to Week 48
measure: Number of subjects with gastrointestinal (GI) AEs
timeFrame: up to Week 48
measure: Absolute values of plasma HIV-1 RNA at Week 24
timeFrame: Week 24
measure: Median change from Baseline in HIV-1 RNA at Week 24
timeFrame: Baseline and Week 24
measure: Absolute values of plasma HIV-1 RNA at Week 48
timeFrame: Week 48
measure: Median change from Baseline in HIV-1 RNA at Week 48
timeFrame: Baseline and Week 48
measure: Absolute values in Cluster of Differentiation 4+ (CD4+) Cell Counts at Week 24
timeFrame: Week 24
measure: Absolute values in Cluster of Differentiation 4+ (CD4+) Cell Counts at Week 48
timeFrame: Week 48
measure: Median change from Baseline in Cluster of Differentiation 4+ (CD4+) Cell Counts at Week 24
timeFrame: Baseline and Week 24
measure: Median change from Baseline in Cluster of Differentiation 4+ (CD4+) Cell Counts at Week 48
timeFrame: Baseline and Week 48
measure: Number of subjects with genotypic resistance at virologic failure
timeFrame: up to Week 48
measure: Number of subjects with phenotypic resistance at virologic failure
timeFrame: up to Week 48
measure: Time to loss of virologic response (TLOVR)
timeFrame: up to Week 48
measure: Medication adherence at Week 24
timeFrame: Week 24
measure: Medication adherence at Week 48
timeFrame: Week 48
measure: Subject treatment satisfaction per the HIV Treatment Satisfaction Questionnaire at Week 24
timeFrame: Week 24
measure: Subject treatment satisfaction per the HIV Treatment Satisfaction Questionnaire at Week 48
timeFrame: Week 48
Other outcomes:
Locations:
city: Beverly Hills
country: United States
facility: GSK Investigational Site
state: California
city: Fresno
country: United States
facility: GSK Investigational Site
state: California
city: Laguna Beach
country: United States
facility: GSK Investigational Site
state: California
city: Long Beach
country: United States
facility: GSK Investigational Site
state: California
city: Los Angeles
country: United States
facility: GSK Investigational Site
state: California
city: Tarzana
country: United States
facility: GSK Investigational Site
state: California
city: Denver
country: United States
facility: GSK Investigational Site
state: Colorado
city: Fort Collins
country: United States
facility: GSK Investigational Site
state: Colorado
city: Washington
country: United States
facility: GSK Investigational Site
state: District of Columbia
city: Fort Lauderdale
country: United States
facility: GSK Investigational Site
state: Florida
city: Fort Lauderdale
country: United States
facility: GSK Investigational Site
state: Florida
city: Fort Lauderdale
country: United States
facility: GSK Investigational Site
state: Florida
city: Fort Myers
country: United States
facility: GSK Investigational Site
state: Florida
city: Jacksonville
country: United States
facility: GSK Investigational Site
state: Florida
city: Miami
country: United States
facility: GSK Investigational Site
state: Florida
city: Orlando
country: United States
facility: GSK Investigational Site
state: Florida
city: Plantation
country: United States
facility: GSK Investigational Site
state: Florida
city: Tampa
country: United States
facility: GSK Investigational Site
state: Florida
city: West Palm Beach
country: United States
facility: GSK Investigational Site
state: Florida
city: Atlanta
country: United States
facility: GSK Investigational Site
state: Georgia
city: Augusta
country: United States
facility: GSK Investigational Site
state: Georgia
city: Des Moines
country: United States
facility: GSK Investigational Site
state: Iowa
city: Wichita
country: United States
facility: GSK Investigational Site
state: Kansas
city: Lexington
country: United States
facility: GSK Investigational Site
state: Kentucky
city: Louisville
country: United States
facility: GSK Investigational Site
state: Kentucky
city: New Orleans
country: United States
facility: GSK Investigational Site
state: Louisiana
city: New Orleans
country: United States
facility: GSK Investigational Site
state: Louisiana
city: Shreveport
country: United States
facility: GSK Investigational Site
state: Louisiana
city: Detroit
country: United States
facility: GSK Investigational Site
state: Michigan
city: Jackson
country: United States
facility: GSK Investigational Site
state: Mississippi
city: Hillsborough
country: United States
facility: GSK Investigational Site
state: New Jersey
city: Somers Point
country: United States
facility: GSK Investigational Site
state: New Jersey
city: Brooklyn
country: United States
facility: GSK Investigational Site
state: New York
city: New York
country: United States
facility: GSK Investigational Site
state: New York
city: Rochester
country: United States
facility: GSK Investigational Site
state: New York
city: Valhalla
country: United States
facility: GSK Investigational Site
state: New York
city: Charlotte
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Charlotte
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Akron
country: United States
facility: GSK Investigational Site
state: Ohio
city: Oklahoma City
country: United States
facility: GSK Investigational Site
state: Oklahoma
city: Tulsa
country: United States
facility: GSK Investigational Site
state: Oklahoma
city: Allentown
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Columbia
country: United States
facility: GSK Investigational Site
state: South Carolina
city: Morristown
country: United States
facility: GSK Investigational Site
state: Tennessee
city: Dallas
country: United States
facility: GSK Investigational Site
state: Texas
city: Dallas
country: United States
facility: GSK Investigational Site
state: Texas
city: Fort Worth
country: United States
facility: GSK Investigational Site
state: Texas
city: Houston
country: United States
facility: GSK Investigational Site
state: Texas
city: Houston
country: United States
facility: GSK Investigational Site
state: Texas
city: Longview
country: United States
facility: GSK Investigational Site
state: Texas
city: Hampton
country: United States
facility: GSK Investigational Site
state: Virginia
city: Ponce
country: Puerto Rico
facility: GSK Investigational Site
Study officials:
affiliation: ViiV Healthcare
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: