Characteristics and Outcomes of Patients Who Received Etravirine and/or Darunavir

Study Overview
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Brief Summary
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The objectives of this data collection activity are to: Describe the baseline demographics, clinical and laboratory profile of patients who ever received darunavir (DRV) and/or etravirine (ETR), at the time of initiation on DRV and/or ETR; Describe the clinical and laboratory profile of patients who ever received DRV and/or ETR every 6 months from the first data collection point through 2021; Describe dynamics in HIV drug resistance mutations among patients who fail treatment on new regimens including DRV and/or ETR; Describe demographics, clinical and laboratory profile of young adults who transition out of the donation program after the age of 25 years at 12 months after their transition.

Detailed Description
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Janssen, the Elizabeth Glaser Pediatric AIDS Foundation (EGPAF), the Partnership for Supply Chain Management (PFSCM), the Collaborative Initiative for Pediatric HIV Education and Research (CIPHER) of the International AIDS Society (IAS), and Right to Care have partnered to implement the New Horizons Collaborative to improve and scale-up pediatric HIV/AIDS care and treatment through increased awareness, research, health systems strengthening, and improved access to HIV/AIDS medicines. A primary source of darunavir (DRV) and etravirine (ETR) for pediatric populations in sub-Saharan Africa is through the New Horizons DRV/ETR Donation Program, which was launched in 2014. Under this program, Janssen provides DRV and/or ETR free of charge to eligible national HIV/AIDS programs in sub-Saharan Africa, for use in children and adolescents up to 25 years of age. Countries currently participating in the New Horizons Collaborative include: Cameroon, Eswatini, Ethiopia, Kenya, Lesotho, Nigeria, Rwanda, Uganda, Zambia, and Zimbabwe. Any country that applies and is approved for receipt of donated product will become eligible for this study when they begin offering donated product to patients. Prior to the inception of the New Horizons Collaborative, no multi-country data were collected regarding the demographic or clinical characteristics of the target patient population (i.e., children, adolescents, and young people < 25 years in need of second- or third-line HIV/AIDS treatment). Therefore, the current activity proposes to collect cross-sectional demographic and clinical data at baseline and every six months for patients receiving DRV and/or ETR across participating New Horizons countries. This activity will comprise data abstraction of key demographic, clinical, laboratory and case history indicators and outcomes on each patient who ever received DRV and/or ETR.

Official Title
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Demographic, Clinical, and Laboratory Characteristics and Outcomes of Patients Who Ever Received Etravirine and/or Darunavir - Multi-country Data Abstraction

Conditions
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HIV/AIDS

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ever received darunavir and/or etravirine. Under age 25. Residing in any of the following countries: Cameroon, Ethiopia, Eswatini, Kenya, Lesotho, Nigeria, Rwanda, Uganda, Zambia, and Zimbabwe. Exclusion Criteria: Above age 25. Residing in a country not participating in the New Horizons Collaborative.

Ages Eligible for Study
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Maximum Age: 25 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical profile of patients who ever received darunavir and/or etravirine | Clinical and laboratory profiles of patients who ever received darunavir and/or etravirine | At initiation of darunavir and/or etravirine, thereafter every six months to the end of 2021, 12 months after turning age 25 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Demographic profile of patients who ever received darunavir and/or etravirine | Age and gender of patients who ever received darunavir and/or etravirine | At initiation of darunavir and/or etravirine | 
| Dynamics in HIV drug resistance mutations | Dynamics in HIV drug resistance mutations among patients who fail treatment | At initiation of darunavir and/or etravirine, thereafter every six months to the end of 2021, 12 months after turning age 25 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV/AIDS, Antiretroviral therapy, Darunavir, Etravirine, Treatment-experienced HIV, Pediatrics, Adolescents, Young people, Drug resistance mutations, Cameroon, Eswatini, Ethiopia, Kenya, Lesotho, Nigeria, Uganda, Zambia, Zimbabwe, Viral load, Protease inhibitor, Non-nucleoside reverse transcriptase inhibitor