At a glance
ClinicalIndex Comparison Record- ✓Age 18 years or older
- ✓Documented HIV-1 infection
- ✓Antiretroviral treatment-naïve (no prior anti-retroviral therapy)
- ✓CD4 count <350 cells/mm³ or AIDS-defining condition
- ✕Age <18 years
- ✕Current pregnancy or breastfeeding
- ✕Any prior antiretroviral therapy
- ✕Severe hepatic impairment (Grade 3 or 4 on ACTG scale)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
"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.
In Brief
A Phase 4 clinical trial evaluating ritonavir-boosted atazanavir and ritonavir-boosted fosamprenavir for HIV Infections. Completed, enrolled 76 participants across 1 site.
Detailed 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 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).
Study Details
Timeline
Interventions
100 mg ritonavir plus 300 mg atazanavir in combination with tenofovir-emtricitabine fixed dose combination given once daily.
100 mg ritonavir plus 1,400 mg fosamprenavir in combination with tenofovir-emtricitabine fixed dose combination given once daily.