Fosamprenavir Versus Other Protease Inhibitors

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Infection, Human Immunodeficiency Virus I

Intervention / Treatment
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* Drug: Fosamprenavir


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment Arm A<br>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<br>* Fosamprenavir<br>|
| Experimental: Treatment Arm B<br>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<br>* Fosamprenavir<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of subjects with HIV-1 RNA less than 400 copies/mL |  | Week 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of subjects with plasma HIV-1 RNA <400 copies/mL |  | Week 48 | 
| Percentage of subjects with plasma HIV-1 RNA <50 copies/mL at Week 24 |  | Week 24 | 
| Percentage of subjects with plasma HIV-1 RNA <50 copies/mL at Week 48 |  | Week 48 | 
| Number of subjects with any adverse events (AEs) |  | up to Week 48 | 
| Number of subjects with gastrointestinal (GI) AEs |  | up to Week 48 | 
| Absolute values of plasma HIV-1 RNA at Week 24 |  | Week 24 | 
| Median change from Baseline in HIV-1 RNA at Week 24 |  | Baseline and Week 24 | 
| Absolute values of plasma HIV-1 RNA at Week 48 |  | Week 48 | 
| Median change from Baseline in HIV-1 RNA at Week 48 |  | Baseline and Week 48 | 
| Absolute values in Cluster of Differentiation 4+ (CD4+) Cell Counts at Week 24 |  | Week 24 | 
| Absolute values in Cluster of Differentiation 4+ (CD4+) Cell Counts at Week 48 |  | Week 48 | 
| Median change from Baseline in Cluster of Differentiation 4+ (CD4+) Cell Counts at Week 24 |  | Baseline and Week 24 | 
| Median change from Baseline in Cluster of Differentiation 4+ (CD4+) Cell Counts at Week 48 |  | Baseline and Week 48 | 
| Number of subjects with genotypic resistance at virologic failure |  | up to Week 48 | 
| Number of subjects with phenotypic resistance at virologic failure |  | up to Week 48 | 
| Time to loss of virologic response (TLOVR) |  | up to Week 48 | 
| Medication adherence at Week 24 |  | Week 24 | 
| Medication adherence at Week 48 |  | Week 48 | 
| Subject treatment satisfaction per the HIV Treatment Satisfaction Questionnaire at Week 24 |  | Week 24 | 
| Subject treatment satisfaction per the HIV Treatment Satisfaction Questionnaire at Week 48 |  | Week 48 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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fosamprenavir LEXIVA non-inferiority safety tolerability