Low Dose Atazanavir/r Versus Standard Dose Atazanavir/r (LASA)
This study is currently recruiting participants.
Verified March 2012 by The HIV Netherlands Australia Thailand Research Collaboration
Sponsor:
The HIV Netherlands Australia Thailand Research Collaboration
Collaborators:
Kirby Institute
National Health Security Office (NHSO)
Information provided by (Responsible Party):
The HIV Netherlands Australia Thailand Research Collaboration
ClinicalTrials.gov Identifier:
NCT01159223
First received: June 4, 2010
Last updated: March 22, 2012
Last verified: March 2012
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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:
Genetics Home Reference related topics:
complement factor I deficiency
MedlinePlus related topics:
HIV/AIDS
U.S. FDA Resources
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
| Estimated Enrollment: | 560 |
| Study Start Date: | May 2011 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | December 2012 (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 |
| 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01159223
Contacts
| Contact: Kiat Ruxrungtham, MD | 662-652-3040 | rkiat@chula.ac.th |
| Contact: Anchalee Avihingsanon, MD | 662-652-3040 ext 107 | anchalee.a@hivnat.org |
Locations
| Thailand | |
| Sanpathong Hospital | Recruiting |
| Sanpathong, Chiang Mai, Thailand | |
| Contact: Virat Klinbuayaem, MD | |
| Principal Investigator: Virat Klinbuayaem, MD | |
| HIV-NAT, Thai Red Cross AIDS Research Centre | Recruiting |
| Bangkok, Thailand, 10330 | |
| Contact: Kiat Ruxrungtham, MD 662-652-3040 rkiat@chula.ac.th | |
| Contact: Anchalee Avihingsanon, MD 662-652-3040 ext 107 anchalee.a@hivnat.org | |
| Principal Investigator: Torsak Bunupuradah, MD | |
| Taksin hospital | Recruiting |
| Bangkok, Thailand | |
| Contact: Supunee Jirajariyavej, MD | |
| Principal Investigator: Supunee Jirajariyavej, MD | |
| Ramathibodi Hospital | Recruiting |
| Bangkok, Thailand | |
| Contact: Sasisopin Kiertiburanakul, MD | |
| Principal Investigator: Sasisopin Kiertiburanakul, MD | |
| BMA Medical College and Vajira Hospital | Recruiting |
| Bangkok, Thailand | |
| Contact: Warangkana Munsakul, MD | |
| Principal Investigator: Warangkana Munsakul, MD | |
| Chiang Rai Regional Hospital | Recruiting |
| Chiang Rai, Thailand | |
| Contact: Pacharee Kantipong, MD | |
| Principal Investigator: Pacharee Kantipong, MD | |
| ChonBuri Hospital | Recruiting |
| ChonBuri, Thailand | |
| Contact: Chureeratana Bowonwatanuwong, MD c.bowon@gmail.com | |
| Principal Investigator: Chureeratana Bowonwatanuwong, MD | |
| Khon Kaen University | Recruiting |
| Khon Kaen, Thailand | |
| Contact: Ploenchan Chetchotisakd, MD ploencha@kku.ac.th | |
| Principal Investigator: Ploenchan Chetchotisakd, MD | |
| Khon Kaen Hospital | Recruiting |
| Khon Kaen, Thailand | |
| Contact: Niramon Leerattanapetch, MD | |
| Principal Investigator: Niramon Leerattanapetch, MD | |
| Bamrasnaradura Infectious Diseases Institute | Recruiting |
| Nonthaburi, Thailand, 11000 | |
| Contact: Wisit Prasithsirikul, MD | |
| Principal Investigator: Wisit Prasithsirikul, MD | |
Sponsors and Collaborators
The HIV Netherlands Australia Thailand Research Collaboration
Kirby Institute
National Health Security Office (NHSO)
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:
No publications provided
| 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: | March 22, 2012 |
| Health Authority: | Thailand: Ethical Committee |
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 Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Ritonavir |
Atazanavir HIV Protease Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 21, 2013