HIV/AIDS Clinical Trial
Official title:
Impact of Hyperbilirubinemia Among HIV Patients Treated With Atazanavir
Verified date | August 2015 |
Source | Bristol-Myers Squibb |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Observational |
The purpose of this study is to determine whether HIV patients on Atazanavir who have Hyperbilirubinemia have different outcomes from those without Hyperbilirubinemia.
Status | Completed |
Enrollment | 1200 |
Est. completion date | May 2015 |
Est. primary completion date | May 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Diagnosis of Human immunodeficiency virus - Treatment with Atazanavir - 18 yrs and older |
Observational Model: Cohort, Time Perspective: Retrospective
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Bristol-Myers Squibb |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Atazanavir persistence among treated patients who develop hyperbilirubinemia compared with Atazanavir-treated patients without evidence of hyperbilirubinemia | 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 | One year after starting Atazanavir | Yes |
Primary | Atazanavir compliance among treated patients who develop hyperbilirubinemia compared with Atazanavir-treated patients without evidence of hyperbilirubinemia | 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 | One year after starting Atazanavir | Yes |
Secondary | Healthcare costs for HBR vs non-HBR patients | 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. Costs will be adjusted into 2013 US dollars using the annual medical care component of the Consumer Price Index (CPI) to reflect inflation between 2003 and 2013 |
1 year | No |
Secondary | Health care resource utilization for HBR vs non-HBR patients | 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. |
1 year | No |
Secondary | Changes (increase, decrease, no change) in the grade of bilirubin laboratory test results during follow-up among Atazanavir-treated patients who develop hyperbilirubinemia | 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 |
1 year | Yes |
Secondary | Rate of Human immunodeficiency virus viral suppression among patients treated with Atazanavir who develop hyperbilirubinemia compared with patients without evidence of hyperbilirubinemia | 1 year | Yes | |
Secondary | Liver function based on Alanine aminotransferase and Aspartate aminotransferase test results among patients treated with Atazanavir who develop hyperbilirubinemia compared with patients without evidence of hyperbilirubinemia | 1 year | Yes |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03413696 -
Effects of Health Literacy and HCV Knowledge on HCV Treatment Willingness in HIV-coinfected Patients
|
||
Completed |
NCT03289676 -
Storytelling Narrative Communication Intervention for Smoking Cessation in Women Living With HIV
|
Phase 1 | |
Completed |
NCT03215901 -
Life Plans Intervention Study
|
N/A | |
Completed |
NCT03268551 -
MEMO-Medical Marijuana and Opioids Study
|
||
Active, not recruiting |
NCT04064567 -
Linking High-Risk Jail Detainees to HIV Pre-Exposure Prophylaxis: PrEP-LINK
|
N/A | |
Completed |
NCT04013295 -
Prize-linked Savings Initiatives for Promoting Better Health and Economic Outcomes in Kenya
|
N/A | |
Recruiting |
NCT04405700 -
Measuring Adverse Pregnancy and Newborn Congenital Outcomes
|
||
Recruiting |
NCT03984136 -
HIV Results Exchange Mechanism on Promoting HIV Testing Among MSM
|
N/A | |
Completed |
NCT02928900 -
Patient Actor Training to Improve HIV Services for Adolescents in Kenya
|
N/A | |
Recruiting |
NCT03268109 -
COGnitive ImpairmenT in Older HIV-infected Patients ≥ 65 Years Old
|
||
Completed |
NCT02797262 -
Measuring and Monitoring Adherence to ART With Pill Ingestible Sensor System
|
N/A | |
Completed |
NCT02376582 -
Safety and Immunogenicity Study of a DNA Vaccine Combined With Protein Vaccine Against HIV/AIDS
|
Phase 1 | |
Completed |
NCT01957865 -
Real-Time Antiretroviral Therapy Adherence Intervention in Uganda
|
N/A | |
Completed |
NCT01616940 -
Minority AIDS Initiative Retention and Re-Engagement Project
|
N/A | |
Terminated |
NCT01443923 -
Boceprevir Drug Combination for Hepatitis C Treatment in People With and Without HIV
|
Phase 4 | |
Completed |
NCT01910714 -
Adapting and Evaluating an EBI to Prevent HIV/AIDS Risk Among Apache Youth
|
N/A | |
Completed |
NCT01084421 -
A Computer-Based Parent/Adolescent HIV Communication Intervention for Latinos
|
N/A | |
Completed |
NCT01596322 -
International HIV Antiretroviral Adherence, Resistance and Survival
|
N/A | |
Completed |
NCT03643705 -
A Nurse-led Intervention to Extend the HIV Treatment Cascade for Cardiovascular Disease Prevention
|
N/A | |
Completed |
NCT03923231 -
Pharmacokinetics of Atazanavir in Special Populations
|