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

NCT01159223 | Completed Phase 4 DMC

• 1 other identifier: HIV - NAT 110
• Study Type: interventional
• Target: 559
• Locations: 1 country
• Sites: 10

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.

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

Outcome Measures

Primary Outcomes (1)

• 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%

  Dec. 2013

Secondary Outcomes (2)

• viral load

  DEc. 2013

• serious adverse events

  Dec. 2013

Study Arms (2)

1

EXPERIMENTAL

ATV/r 200 mg/100 mg OD

Drug: ATV/r

2

EXPERIMENTAL

ATV/r 300 mg/100 mg OD

Drug: ATV/r

Interventions

ATV/r DRUG

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

1; 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The HIV Netherlands Australia Thailand Research Collaboration: lead
• Kirby Institute: collaborator
• National Health Security Office, Thailand: collaborator

Study Sites (10)

Chiang Rai Regional Hospital

Chiang Rai, Changwat Chiang Rai, Thailand

Location

ChonBuri Hospital

Chon Buri, Changwat Chon Buri, Thailand

Location

Khon Kaen University

Khon Kaen, Changwat Khon Kaen, Thailand

Location

Bamrasnaradura Infectious Diseases Institute

Nonthaburi, Changwat Nonthaburi, 11000, Thailand

Location

Sanpathong Hospital

Sanpathong, Chiang Mai, Thailand

Location

HIV-NAT, Thai Red Cross AIDS Research Centre

Bangkok, 10330, Thailand

Location

BMA Medical College and Vajira Hospital

Bangkok, Thailand

Location

Ramathibodi Hospital

Bangkok, Thailand

Location

Taksin hospital

Bangkok, Thailand

Location

Khon Kaen Hospital

Khon Kaen, Thailand

Location

Related Publications (1)

• 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.

  PMID: 27470026 RESULT

Related Links

• HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT)

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Kiat Ruxrungtham, MD

  HIV-NAT, The Thai Red Cross AIDS Research Centre (TRCARC), and Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2010
• First Posted: July 9, 2010
• Study Start: May 1, 2011
• Primary Completion: December 1, 2014
• Study Completion: June 1, 2015
• Last Updated: August 18, 2016

Record last verified: 2016-08

Data Sharing

• IPD Sharing: Will share

Locations

TH (10)