Clinical trial NCT01159223: Low Dose Atazanavir/r Versus Standard Dose Atazanavir/r (LASA)
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: HIV Infections
Keywords: atazanavir / ritonavir
low dose
noninferiority
safety and efficacy
efficacy and safety of lower dose atazanavir/ritonavir in suppressed HIV-infected adults
Lead sponsor: The HIV Netherlands Australia Thailand Research Collaboration
Sponsor class: OTHER
Collaborators: name: Kirby Institute
name: National Health Security Office, Thailand
First posted: 2010-07-09
Enrollment: 559
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 responders (plasma HIV RNA \< 200 copies/mL) at 48 weeks in ARV-experienced HIV-1 infected subjects.

Eligibility criteria: Inclusion Criteria:

1. HIV infected adults aged more than or equal to 18 years
2. Received ritonavir boosted PI-based HAART for \>3 months prior screening visit
3. History of HIV RNA \< 50 copies/ml within 12 months prior to screening visit
4. HIV-RNA \< 50 copies/ml at screening visit
5. Signed written informed consent

Exclusion Criteria:

1. Active AIDS-defining disease or active opportunistic infection
2. History of virological failure (plasma HIV-RNA ≥1,000 copies/ml) while using any ritonavir boosted PI-based HAART
3. Pregnancy or lactation at screening visit
4. Relevant history or current conditions or illnesses that might interfere with drug absorption, distribution, metabolism or excretion e.g. chronic diarrhea, malabsorption
5. Use of concomitant medication that may interfere with the pharmacokinetics of the study drugs e.g. rifampicin, proton pump inhibitor
6. History of sensitivity/idiosyncrasy to the drug or chemically related compounds which may be employed in the study
7. ALT ≥200 IU/L at screening visit
8. Creatinine clearance \< 60 c.c. per min by Cockroft-Gault formula at screening visit

Primary outcomes:
measure: noninferiority
timeFrame: Dec. 2013
Secondary outcomes:
measure: viral load
timeFrame: DEc. 2013
measure: serious adverse events
timeFrame: Dec. 2013
Other outcomes:
Locations:
city: Sanpathong
country: Thailand
facility: Sanpathong Hospital
state: Chiang Mai
city: Bangkok
country: Thailand
facility: HIV-NAT, Thai Red Cross AIDS Research Centre
city: Bangkok
country: Thailand
facility: BMA Medical College and Vajira Hospital
city: Bangkok
country: Thailand
facility: Ramathibodi Hospital
city: Bangkok
country: Thailand
facility: Taksin hospital
city: Chiang Rai
country: Thailand
facility: Chiang Rai Regional Hospital
city: ChonBuri
country: Thailand
facility: ChonBuri Hospital
city: Khon Kaen
country: Thailand
facility: Khon Kaen Hospital
city: Khon Kaen
country: Thailand
facility: Khon Kaen University
city: Nonthaburi
country: Thailand
facility: Bamrasnaradura Infectious Diseases Institute
Study officials:
affiliation: HIV-NAT, The Thai Red Cross AIDS Research Centre (TRCARC), and Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand
name: Kiat Ruxrungtham, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bunupuradah T, Kiertiburanakul S, Avihingsanon A, Chetchotisakd P, Techapornroong M, Leerattanapetch N, Kantipong P, Bowonwatanuwong C, Banchongkit S, Klinbuayaem V, Mekviwattanawong S, Nimitvilai S, Jirajariyavej S, Prasithsirikul W, Munsakul W, Bhakeecheep S, Chaivooth S, Phanuphak P, Cooper DA, Apornpong T, Kerr SJ, Emery S, Ruxrungtham K; LASA Study Group. Low-dose versus standard-dose ritonavir-boosted atazanavir in virologically suppressed Thai adults with HIV (LASA): a randomised, open-label, non-inferiority trial. Lancet HIV. 2016 Aug;3(8):e343-e350. doi: 10.1016/S2352-3018(16)30010-8. Epub 2016 May 24.