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

NCT ID: NCT01159223

Last Updated: 2016-08-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 559 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-05-31
• Study Completion Date: 2015-06-30

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.

Conditions

HIV Infections

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

1

ATV/r 200 mg/100 mg OD

Group Type: EXPERIMENTAL

ATV/r

Intervention Type: 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

2

ATV/r 300 mg/100 mg OD

Group Type: EXPERIMENTAL

ATV/r

Intervention Type: 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

Interventions

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

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kirby Institute

OTHER_GOV

Sponsor Role: collaborator

National Health Security Office, Thailand

OTHER

Sponsor Role: collaborator

The HIV Netherlands Australia Thailand Research Collaboration

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kiat Ruxrungtham, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Chiang Rai Regional Hospital

Chiang Rai, Changwat Chiang Rai, Thailand

ChonBuri Hospital

Chon Buri, Changwat Chon Buri, Thailand

Khon Kaen University

Khon Kaen, Changwat Khon Kaen, Thailand

Bamrasnaradura Infectious Diseases Institute

Nonthaburi, Changwat Nonthaburi, Thailand

Sanpathong Hospital

Sanpathong, Chiang Mai, Thailand

HIV-NAT, Thai Red Cross AIDS Research Centre

Bangkok, , Thailand

BMA Medical College and Vajira Hospital

Bangkok, , Thailand

Ramathibodi Hospital

Bangkok, , Thailand

Taksin hospital

Bangkok, , Thailand

Khon Kaen Hospital

Khon Kaen, , Thailand

Countries

Thailand

References

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.

Reference Type: RESULT

PMID: 27470026 (View on PubMed)

Related Links

http://www.hivnat.org

HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT)

Other Identifiers

HIV - NAT 110

Identifier Type: -

Identifier Source: org_study_id