Low Dose Atazanavir/r Versus Standard Dose Atazanavir/r (LASA)
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| ClinicalTrials.gov Identifier: NCT01159223 |
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Recruitment Status
:
Completed
First Posted
: July 9, 2010
Last Update Posted
: August 18, 2016
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Sponsor:
The HIV Netherlands Australia Thailand Research Collaboration
Collaborators:
Kirby Institute
National Health Security Office, Thailand
Information provided by (Responsible Party):
The HIV Netherlands Australia Thailand Research Collaboration
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| HIV Infections | Drug: ATV/r | Phase 4 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 559 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Triple (Participant, Care Provider, Investigator) |
| Primary Purpose: | Treatment |
| 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 Start Date : | May 2011 |
| Actual Primary Completion Date : | December 2014 |
| Actual Study Completion Date : | June 2015 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
HIV/AIDS
U.S. FDA Resources
| Arm | Intervention/treatment |
|---|---|
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Experimental: 1
ATV/r 200 mg/100 mg OD
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Drug: 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
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Experimental: 2
ATV/r 300 mg/100 mg OD
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Drug: 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
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Primary Outcome Measures
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- noninferiority [ Time Frame: Dec. 2013 ]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 [ Time Frame: DEc. 2013 ]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 [ Time Frame: Dec. 2013 ]Changes in HDL, LDL, cholesterol, triglycerides and bilirubin, or having grade 3 and 4 laboratory adverse events
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| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01159223
Locations
| Thailand | |
| Sanpathong Hospital | |
| Sanpathong, Chiang Mai, Thailand | |
| HIV-NAT, Thai Red Cross AIDS Research Centre | |
| Bangkok, Thailand, 10330 | |
| BMA Medical College and Vajira Hospital | |
| Bangkok, Thailand | |
| Ramathibodi Hospital | |
| Bangkok, Thailand | |
| Taksin hospital | |
| Bangkok, Thailand | |
| Chiang Rai Regional Hospital | |
| Chiang Rai, Thailand | |
| ChonBuri Hospital | |
| ChonBuri, Thailand | |
| Khon Kaen Hospital | |
| Khon Kaen, Thailand | |
| Khon Kaen University | |
| Khon Kaen, Thailand | |
| Bamrasnaradura Infectious Diseases Institute | |
| Nonthaburi, Thailand, 11000 | |
Sponsors and Collaborators
The HIV Netherlands Australia Thailand Research Collaboration
Kirby Institute
National Health Security Office, Thailand
Investigators
| Principal Investigator: | Kiat Ruxrungtham, MD | HIV-NAT, The Thai Red Cross AIDS Research Centre (TRCARC), and Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand |
Additional Information:
Publications of Results:
| Responsible Party: | The HIV Netherlands Australia Thailand Research Collaboration |
| ClinicalTrials.gov Identifier: | NCT01159223 History of Changes |
| Other Study ID Numbers: |
HIV - NAT 110 |
| First Posted: | July 9, 2010 Key Record Dates |
| Last Update Posted: | August 18, 2016 |
| Last Verified: | August 2016 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Plan Description: | study protocol available at www.hivnat.org |
Keywords provided by The HIV Netherlands Australia Thailand Research Collaboration:
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atazanavir / ritonavir low dose noninferiority safety and efficacy efficacy and safety of lower dose atazanavir/ritonavir in suppressed HIV-infected adults |
Additional relevant MeSH terms:
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HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Ritonavir Atazanavir Sulfate |
HIV Protease Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Cytochrome P-450 CYP3A Inhibitors Cytochrome P-450 Enzyme Inhibitors |