Phase 4 Completed N=76 Randomized Treatment

"The Once A Day Protease Inhibitor Regimens"

HIV

Source: ClinicalTrials.gov NCT00242216 ↗

Enrolled (actual)

Serious AEs

19.7%

Results posted

Oct 2013

Primary outcomePrimary: Proportion of Patient With Viral Load Less Than 400 Copies/mL — 89; 73 percentage

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).

Outcome Measures

Outcome	Result	p-value
PRIMARY Proportion of Patient With Viral Load Less Than 400 Copies/mL	89; 73	—
SECONDARY CD4 Cell Count Change From Baseline During Treatment.	139; 117	—

Eligibility Criteria

Inclusion Criteria

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 1,000 copies/mL

Exclusion Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00242216). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.