"The Once A Day Protease Inhibitor Regimens"
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|ClinicalTrials.gov Identifier: NCT00242216|
Recruitment Status : Completed
First Posted : October 19, 2005
Results First Posted : October 17, 2013
Last Update Posted : January 15, 2014
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 treatment of ARV-naïve HIV-infected people. This study was designed to demonstrate if a HAART regimen containing ATV/r is not inferior to a HAART regimen containing fAPV/r, in ARV-naïve patients over a 96-week period.
This is a phase IV, single center, randomized, open label, 2-arm clinical trial in ARV therapy-naïve patients with HIV-1 RNA >1,000 copes/mL and CD4 cell count <350 cells/mm3. Patients will be randomized to receive tenofovir and emtricitabine plus either ATV (300mg qd) and ritonavir (100mg qd) or fAPV (1400mg qd) and ritonavir (200mg qd).
|Condition or disease||Intervention/treatment||Phase|
|HIV Infections||Drug: ritonavir-boosted atazanavir Drug: ritonavir-boosted fosamprenavir||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||76 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||"PIQD: The Once a Day Protease Inhibitor Regimens." Ritonavir Boosted Atazanavir vs. Ritonavir Boosted Fosamprenavir Used in Combination With Tenofovir and Emtricitabine in HIV-1 Infected Antiretroviral Treatment-Naïve Patients.|
|Study Start Date :||May 2004|
|Actual Primary Completion Date :||March 2010|
|Actual Study Completion Date :||March 2010|
Active Comparator: Atazanavir oral once daily
Drug: ritonavir-boosted atazanavir
100 mg ritonavir plus 300 mg atazanavir in combination with tenofovir-emtricitabine fixed dose combination given once daily.
Other Name: Reyataz plus Norvir
Active Comparator: Fosamprenavir oral once daily
Drug: ritonavir-boosted fosamprenavir
100 mg ritonavir plus 1,400 mg fosamprenavir in combination with tenofovir-emtricitabine fixed dose combination given once daily.
Other Name: Lexiva plus Norvir
- Proportion of Patient With Viral Load Less Than 400 Copies/mL [ Time Frame: 24 weeks ]
- CD4 Cell Count Change From Baseline During Treatment. [ Time Frame: 24 weeks. ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00242216
|United States, Texas|
|Thomas Street Health Center|
|Houston, Texas, United States, 77009|
|Principal Investigator:||Roberto C Arduino, MD||The University of Texas Health Science Center, Houston|