An observational study in HIV/AIDS, sponsored by Elizabeth Glaser Pediatric AIDS Foundation. Completed at 5 sites in 5 countries. Open to participants aged Up to 25 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-09.
Sponsored by Elizabeth Glaser Pediatric AIDS Foundation · Observational
The objectives of this data collection activity are to:
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.
3,035 studies on the registry are indexed under Acquired Immunodeficiency Syndrome; 306 are open to participants now.
This study's enrollment of 871 is above the median of 287 across 503 observational studies indexed under Acquired Immunodeficiency Syndrome.
Browse Acquired Immunodeficiency Syndrome studies →Elizabeth Glaser Pediatric AIDS Foundation is the lead sponsor of 30 studies on the registry; none are open to participants now.
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All patients who ever received darunavir and/or etravirine before turning age 25 and residing in the following countries: Cameroon, Eswatini, Kenya, Lesotho, Nigeria, Rwanda, Uganda, Zambia, Zimbabwe.
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Exclusion Criteria:
Clinical profile of patients who ever received darunavir and/or etravirine
Clinical and laboratory profiles of patients who ever received darunavir and/or etravirine
Time frame: At initiation of darunavir and/or etravirine, thereafter every six months to the end of 2021, 12 months after turning age 25
Demographic profile of patients who ever received darunavir and/or etravirine
Age and gender of patients who ever received darunavir and/or etravirine
Time frame: At initiation of darunavir and/or etravirine
Dynamics in HIV drug resistance mutations
Dynamics in HIV drug resistance mutations among patients who fail treatment
Time frame: At initiation of darunavir and/or etravirine, thereafter every six months to the end of 2021, 12 months after turning age 25
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Acquired Immunodeficiency Syndrome →
Elizabeth Glaser Pediatric AIDS Foundation