"The Once A Day Protease Inhibitor Regimens"
|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. ]
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|