Low Dose Atazanavir/r Versus Standard Dose Atazanavir/r (LASA)
This study has been completed.
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
ClinicalTrials.gov Identifier:
NCT01159223
First received: June 4, 2010
Last updated: August 17, 2016
Last verified: August 2016
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
HIV Infections |
Drug: ATV/r |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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 |
Resource links provided by NLM:
Further study details as provided by The HIV Netherlands Australia Thailand Research Collaboration:
Primary Outcome Measures:
- noninferiority [ Time Frame: Dec. 2013 ] [ Designated as safety issue: Yes ]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 ] [ Designated as safety issue: Yes ]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 ] [ Designated as safety issue: Yes ]Changes in HDL, LDL, cholesterol, triglycerides and bilirubin, or having grade 3 and 4 laboratory adverse events
| Enrollment: | 559 |
| Study Start Date: | May 2011 |
| Study Completion Date: | June 2015 |
| Primary Completion Date: | December 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
ATV/r 200 mg/100 mg OD
|
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
|
|
Experimental: 2
ATV/r 300 mg/100 mg OD
|
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
|
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| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Genders Eligible for Study: | Both |
| 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
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01159223
Please refer to this study by its ClinicalTrials.gov identifier: 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 |
More Information
Additional Information:
Publications:
| Responsible Party: | The HIV Netherlands Australia Thailand Research Collaboration |
| ClinicalTrials.gov Identifier: | NCT01159223 History of Changes |
| Other Study ID Numbers: | HIV - NAT 110 |
| Study First Received: | June 4, 2010 |
| Last Updated: | August 17, 2016 |
| Health Authority: | Thailand: Ethical Committee |
| Individual Participant Data | |
| Plan to Share IPD: | Yes |
| Plan Description: | study protocol available at www.hivnat.org |
Keywords provided by The HIV Netherlands Australia Thailand Research Collaboration:
|
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:
|
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 |
ClinicalTrials.gov processed this record on September 23, 2016