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| Name | Class |
|---|---|
| Kirby Institute | OTHER_GOV |
| National Health Security Office, Thailand | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | ATV/r 200 mg/100 mg OD |
|
| 2 | Experimental | ATV/r 300 mg/100 mg OD |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| viral load | A secondary efficacy analysis will explore the impact of changing the lower limit of detection of viral load to <50 copies/mL | DEc. 2013 |
| serious adverse events | Changes in HDL, LDL, cholesterol, triglycerides and bilirubin, or having grade 3 and 4 laboratory adverse events |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kiat Ruxrungtham, MD | HIV-NAT, The Thai Red Cross AIDS Research Centre (TRCARC), and Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chiang Rai Regional Hospital | Chiang Rai | Changwat Chiang Rai | Thailand | |||
| ChonBuri Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27470026 | Result | 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. |
| Label | URL |
|---|---|
| HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT) | View source |
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study protocol available at www.hivnat.org
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| ID | Term |
|---|---|
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
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|
| Dec. 2013 |
| Chon Buri |
| Changwat Chon Buri |
| Thailand |
| Khon Kaen University | Khon Kaen | Changwat Khon Kaen | Thailand |
| Bamrasnaradura Infectious Diseases Institute | Nonthaburi | Changwat Nonthaburi | 11000 | Thailand |
| Sanpathong Hospital | Sanpathong | Chiang Mai | Thailand |
| HIV-NAT, Thai Red Cross AIDS Research Centre | Bangkok | 10330 | Thailand |
| BMA Medical College and Vajira Hospital | Bangkok | Thailand |
| Ramathibodi Hospital | Bangkok | Thailand |
| Taksin hospital | Bangkok | Thailand |
| Khon Kaen Hospital | Khon Kaen | Thailand |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |