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

Primary Purpose

HIV Infections

Status
Completed
Phase
Phase 4
Locations
Thailand
Study Type
Interventional
Intervention
ATV/r
Sponsored by
The HIV Netherlands Australia Thailand Research Collaboration
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring atazanavir / ritonavir, low dose, noninferiority, safety and efficacy, efficacy and safety of lower dose atazanavir/ritonavir in suppressed HIV-infected adults

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Sanpathong Hospital
  • HIV-NAT, Thai Red Cross AIDS Research Centre
  • BMA Medical College and Vajira Hospital
  • Ramathibodi Hospital
  • Taksin hospital
  • Chiang Rai Regional Hospital
  • ChonBuri Hospital
  • Khon Kaen Hospital
  • Khon Kaen University
  • Bamrasnaradura Infectious Diseases Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

1

2

Arm Description

ATV/r 200 mg/100 mg OD

ATV/r 300 mg/100 mg OD

Outcomes

Primary Outcome Measures

noninferiority
ATV/r 200/100 mg will be judged to be non-inferior to ATV 300/100mg if the lower limit of the 95% confidence interval for the difference in proportion of patients with virological response between the two groups does not exceed -10%

Secondary Outcome Measures

viral load
A secondary efficacy analysis will explore the impact of changing the lower limit of detection of viral load to <50 copies/mL
serious adverse events
Changes in HDL, LDL, cholesterol, triglycerides and bilirubin, or having grade 3 and 4 laboratory adverse events

Full Information

First Posted
June 4, 2010
Last Updated
August 17, 2016
Sponsor
The HIV Netherlands Australia Thailand Research Collaboration
Collaborators
Kirby Institute, National Health Security Office, Thailand
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1. Study Identification

Unique Protocol Identification Number
NCT01159223
Brief Title
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

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
May 2011 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The HIV Netherlands Australia Thailand Research Collaboration
Collaborators
Kirby Institute, National Health Security Office, Thailand

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
atazanavir / ritonavir, low dose, noninferiority, safety and efficacy, efficacy and safety of lower dose atazanavir/ritonavir in suppressed HIV-infected adults

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
559 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
ATV/r 200 mg/100 mg OD
Arm Title
2
Arm Type
Experimental
Arm Description
ATV/r 300 mg/100 mg OD
Intervention Type
Drug
Intervention Name(s)
ATV/r
Intervention Description
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
Primary Outcome Measure Information:
Title
noninferiority
Description
ATV/r 200/100 mg will be judged to be non-inferior to ATV 300/100mg if the lower limit of the 95% confidence interval for the difference in proportion of patients with virological response between the two groups does not exceed -10%
Time Frame
Dec. 2013
Secondary Outcome Measure Information:
Title
viral load
Description
A secondary efficacy analysis will explore the impact of changing the lower limit of detection of viral load to <50 copies/mL
Time Frame
DEc. 2013
Title
serious adverse events
Description
Changes in HDL, LDL, cholesterol, triglycerides and bilirubin, or having grade 3 and 4 laboratory adverse events
Time Frame
Dec. 2013

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kiat Ruxrungtham, MD
Organizational Affiliation
HIV-NAT, The Thai Red Cross AIDS Research Centre (TRCARC), and Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sanpathong Hospital
City
Sanpathong
State/Province
Chiang Mai
Country
Thailand
Facility Name
HIV-NAT, Thai Red Cross AIDS Research Centre
City
Bangkok
ZIP/Postal Code
10330
Country
Thailand
Facility Name
BMA Medical College and Vajira Hospital
City
Bangkok
Country
Thailand
Facility Name
Ramathibodi Hospital
City
Bangkok
Country
Thailand
Facility Name
Taksin hospital
City
Bangkok
Country
Thailand
Facility Name
Chiang Rai Regional Hospital
City
Chiang Rai
Country
Thailand
Facility Name
ChonBuri Hospital
City
ChonBuri
Country
Thailand
Facility Name
Khon Kaen Hospital
City
Khon Kaen
Country
Thailand
Facility Name
Khon Kaen University
City
Khon Kaen
Country
Thailand
Facility Name
Bamrasnaradura Infectious Diseases Institute
City
Nonthaburi
ZIP/Postal Code
11000
Country
Thailand

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
study protocol available at www.hivnat.org
Citations:
PubMed Identifier
27470026
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.
Results Reference
result
Links:
URL
http://www.hivnat.org
Description
HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT)

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

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