Fosamprenavir Versus Other Protease Inhibitors
Status: | Completed |
---|---|
Conditions: | Infectious Disease, HIV / AIDS, HIV / AIDS, HIV / AIDS |
Therapuetic Areas: | Immunology / Infectious Diseases |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 6/10/2017 |
Start Date: | December 2004 |
End Date: | June 2007 |
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.
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.
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.
We found this trial at
40
sites
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