Trial to Compare Lower Dose to Standard Dose Boosted Atazanavir /Ritonavir (ATV)
Summary
The purpose of this study is to compare 2 different doses of ATV.
Description
We are interested in once daily ATV/r 200/100 mg OD because ATV dose reduction may reduce toxicity and cost compared to standard dose ATV/r at 300/100mg OD. There are limited prospective randomized studies evaluating the long term efficacy and safety of lower dose ATV/r OD dose in combination of NRTIs in HIV-1 pretreated patients. We believe that the efficacy of ATV/r given at 200/100mg daily in Thai patients will be equivalent to ATV/r 300/100mg once daily when combined with 2NRTIs, and that the low dose ATV/r will have better safety, tolerability profile, and cost saving while maintaining good CD4 and HIV RNA outcomes.
Study Design
Allocation: Randomized, Control: Dose Comparison, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label
Conditions
HIV Infections
Intervention
Atazanavir, Atazanavir
Location
HIV-NAT, Thai Red Cross AIDS Research Centre
Bangkok
Thailand
10330
Status
Not yet recruiting
Source
The HIV Netherlands Australia Thailand Research Collaboration
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT01159223
- Information obtained from ClinicalTrials.gov on July 15, 2010
Published on BioPortfolio: 2014-08-27T03:12:19-0400
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Medical and Biotech [MESH] Definitions
Atazanavir Sulfate
An azapeptide and HIV-PROTEASE INHIBITOR that is used in the treatment of HIV INFECTIONS and AIDS in combination with other ANTI-HIV AGENTS.
Encephalitis, Viral
Inflammation of brain parenchymal tissue as a result of viral infection. Encephalitis may occur as primary or secondary manifestation of TOGAVIRIDAE INFECTIONS; HERPESVIRIDAE INFECTIONS; ADENOVIRIDAE INFECTIONS; FLAVIVIRIDAE INFECTIONS; BUNYAVIRIDAE INFECTIONS; PICORNAVIRIDAE INFECTIONS; PARAMYXOVIRIDAE INFECTIONS; ORTHOMYXOVIRIDAE INFECTIONS; RETROVIRIDAE INFECTIONS; and ARENAVIRIDAE INFECTIONS.
Meningitis, Viral
Viral infections of the leptomeninges and subarachnoid space. TOGAVIRIDAE INFECTIONS; FLAVIVIRIDAE INFECTIONS; RUBELLA; BUNYAVIRIDAE INFECTIONS; ORBIVIRUS infections; PICORNAVIRIDAE INFECTIONS; ORTHOMYXOVIRIDAE INFECTIONS; RHABDOVIRIDAE INFECTIONS; ARENAVIRIDAE INFECTIONS; HERPESVIRIDAE INFECTIONS; ADENOVIRIDAE INFECTIONS; JC VIRUS infections; and RETROVIRIDAE INFECTIONS may cause this form of meningitis. Clinical manifestations include fever, headache, neck pain, vomiting, PHOTOPHOBIA, and signs of meningeal irritation. (From Joynt, Clinical Neurology, 1996, Ch26, pp1-3)
Paramyxoviridae Infections
Infections with viruses of the family PARAMYXOVIRIDAE. This includes MORBILLIVIRUS INFECTIONS; RESPIROVIRUS INFECTIONS; PNEUMOVIRUS INFECTIONS; HENIPAVIRUS INFECTIONS; AVULAVIRUS INFECTIONS; and RUBULAVIRUS INFECTIONS.
Central Nervous System Infections
Pathogenic infections of the brain, spinal cord, and meninges. DNA VIRUS INFECTIONS; RNA VIRUS INFECTIONS; BACTERIAL INFECTIONS; MYCOPLASMA INFECTIONS; SPIROCHAETALES INFECTIONS; fungal infections; PROTOZOAN INFECTIONS; HELMINTHIASIS; and PRION DISEASES may involve the central nervous system as a primary or secondary process.
