Status:
COMPLETED
"The Once A Day Protease Inhibitor Regimens"
Lead Sponsor:
The University of Texas Health Science Center, Houston
Conditions:
HIV Infections
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Atazanavir (ATV) and fosamprenavir (fAPV) are new protease inhibitors that can be administered once-a-day and boosted with ritonavir (r). Prior studies have demonstrated that both are effective in tre...
Detailed Description
Over the past decade, there have been significant advances toward fighting the progression of HIV disease. Current treatment strategies consist of utilization of potent combination antiretroviral ther...
Eligibility Criteria
Inclusion
- 18 years of age or older.
- Patient agrees to participate in the study by giving written informed consent.
- Documentation of HIV infection.
- No prior treatment with any anti-retroviral agent.
- CD4 cell count \< 350 cells x mm3 or with an AIDS defining condition.
- Viral load \> 1,000 copies/mL
Exclusion
- Less than 18 years old.
- Current pregnancy or breastfeeding.
- Any previous antiretroviral regimen.
- Severe hepatic impairment that precludes the use of either study drug. This will be defined as any laboratory value of Grade 3 or 4 on the ACTG scale.
- Use of any contra-indicated medication as defined in the package insert for each drug.
- Any condition that, in the judgment of the investigator, precludes successful participation in the study.
Key Trial Info
Start Date :
May 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2010
Estimated Enrollment :
76 Patients enrolled
Trial Details
Trial ID
NCT00242216
Start Date
May 1 2004
End Date
March 1 2010
Last Update
January 15 2014
Active Locations (1)
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1
Thomas Street Health Center
Houston, Texas, United States, 77009