Status:
COMPLETED
Low Dose Atazanavir/r Versus Standard Dose Atazanavir/r (LASA)
Lead Sponsor:
The HIV Netherlands Australia Thailand Research Collaboration
Collaborating Sponsors:
Kirby Institute
National Health Security Office, Thailand
Conditions:
HIV Infections
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 r...
Eligibility Criteria
Inclusion
- HIV infected adults aged more than or equal to 18 years
- Received ritonavir boosted PI-based HAART for \>3 months prior screening visit
- History of HIV RNA \< 50 copies/ml within 12 months prior to screening visit
- HIV-RNA \< 50 copies/ml at screening visit
- Signed written informed consent
Exclusion
- Active AIDS-defining disease or active opportunistic infection
- History of virological failure (plasma HIV-RNA ≥1,000 copies/ml) while using any ritonavir boosted PI-based HAART
- Pregnancy or lactation at screening visit
- Relevant history or current conditions or illnesses that might interfere with drug absorption, distribution, metabolism or excretion e.g. chronic diarrhea, malabsorption
- Use of concomitant medication that may interfere with the pharmacokinetics of the study drugs e.g. rifampicin, proton pump inhibitor
- History of sensitivity/idiosyncrasy to the drug or chemically related compounds which may be employed in the study
- ALT ≥200 IU/L at screening visit
- Creatinine clearance \< 60 c.c. per min by Cockroft-Gault formula at screening visit
Key Trial Info
Start Date :
May 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2015
Estimated Enrollment :
559 Patients enrolled
Trial Details
Trial ID
NCT01159223
Start Date
May 1 2011
End Date
June 1 2015
Last Update
August 18 2016
Active Locations (10)
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1
Chiang Rai Regional Hospital
Chiang Rai, Changwat Chiang Rai, Thailand
2
ChonBuri Hospital
Chon Buri, Changwat Chon Buri, Thailand
3
Khon Kaen University
Khon Kaen, Changwat Khon Kaen, Thailand
4
Bamrasnaradura Infectious Diseases Institute
Nonthaburi, Changwat Nonthaburi, Thailand, 11000