"The Once A Day Protease Inhibitor Regimens"
Completed · Phase 4
Conditions studied: HIV Infections
In brief
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).
Key facts
- Study ID
- NCT00242216
- Run by
- The University of Texas Health Science Center, Houston
- People needed
- 76
- Starts
- 2004-05-01
- Expected to finish
- 2010-03-01
- Last updated by the study team
- 2014-01-15
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- Thomas Street Health Center — Houston, Texas, United States
Full record on ClinicalTrials.gov
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