NCT01159223

Low Dose Atazanavir/r Versus Standard Dose Atazanavir/r (LASA)

A Multicenter Randomized Study to Compare the Efficacy and Safety of Lower Dose Atazanavir /Ritonavir (ATV/r 200/100 OD) Versus Standard Dose (ATV/r 300/100 mg OD) in Combination With 2NRTIs in Well Virology Suppressed HIV-infected Adults

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 559 (actual)
• Sponsor: The HIV Netherlands Australia Thailand Research Collaboration · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will compare the efficacy and safety of ATV/r at either 200/100 mg or 300/100mg given daily in Thai patients in combination with 2NRTIs.

Detailed description

To demonstrate non-inferiority of treatment with atazanavir/ritonavir (ATV/r) 200/100 mg once daily (OD) compared to the control group (ATV/r 300/100 mg OD) in regards to the proportion of virologic responders (plasma HIV RNA \< 200 copies/mL) at 48 weeks in ARV-experienced HIV-1 infected subjects.

Conditions

• HIV Infections

Interventions

Type	Name	Description
DRUG	ATV/r	All participants will be randomized to take ATV/r 200 mg/100 mg OD or ATV/r 300/100 mg OD. NRTIs background regimens will remain unchanged if possible. NRTIs background may include zidovudine/lamivudine, zidovudine plus ddI, ddI plus lamivudine, tenofovir plus lamivudine, tenofovir/emtricitabine, zidovudine plus tenofovir. NRTI backbone could be switched or modified due to toxicity or intolerance

Timeline

• Start date: 2011-05-01
• Primary completion: 2014-12-01
• Completion: 2015-06-01
• First posted: 2010-07-09
• Last updated: 2016-08-18

Locations

10 sites across 1 country: Thailand