Integration of Hypertension Management in HIV Care in Uganda
NCT05609513
Acquired Immunodeficiency Syndrome, Blood-Borne Infections
Kampala, Uganda
View Trial DetailsNCT Number: NCT02532673
The purpose of this study is to determine whether HIV patients on Atazanavir who have Hyperbilirubinemia have different outcomes from those without Hyperbilirubinemia.
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Notify Me18 year and older
All sexes
Observational
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Time frame: One year after starting Atazanavir
Discontinuation rate, defined as proportion of patients having discontinued Atazanavir at 1 year, of HBR vs. non-HBR patients. Persistence, defined as mean days to Atazanavir discontinuation, of HBR vs non-HBR patients. Compliance defined as mean medication-possession ratio of HBR vs non-HBR patients
Time frame: One year after starting Atazanavir
Discontinuation rate, defined as proportion of patients having discontinued Atazanavir at 1 year, of HBR vs. non-HBR patients. Persistence, defined as mean days to Atazanavir discontinuation, of HBR vs non-HBR patients. Compliance defined as mean medication-possession ratio of HBR vs non-HBR patients
Time frame: 1 year
Health care costs:
Health care costs will be computed as the combined health plan and patient paid amounts for all claims in the 12-month post-index period. Mean costs will be calculated for total costs, medical costs, pharmacy costs, ambulatory costs, emergency services costs, inpatient costs, and other costs.
Time frame: 1 year
Health care resource utilization:
Binary indicators and counts of mean number of ambulatory visits (office and outpatient), ER visits, and inpatient admissions over 12 months will be calculated. Total number of inpatient days and mean length of inpatient stay will also will be captured.
Time frame: 1 year
Grade of the bilirubin test result will be captured and defined as follows: Grade 0 = normal; Grade 1 ≥ 1.0 to 1.5 times the upper limit of normal (x ULN), Grade 2 ≥1.5 to 2.5 x ULN; Grade 3 ≥ 2.5 to 5 x ULN; Grade 4 ≥ 5 x ULN
The upper limit of normal range was used to standardize the laboratory results across different lab systems. Each laboratory vendor provides a normal range for their results. These results were then transformed based on the normal ranges provided. The ranges below were used to categorize the patients:
=0, if result in normal rage
=1, if result > 1.0-1.5 times the upper limit of normal (x ULN)
=2, if result > 1.5-2.5 x ULN
=3, if result > 2.5-5 x ULN
=4, if result > 5 x ULN
Time frame: 1 year
Time frame: 1 year
Bristol-Myers Squibb
Industry
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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