Characteristics and Outcomes of Patients Who Received Etravirine and/or Darunavir (NewHorizon)
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ClinicalTrials.gov Identifier: NCT04194021 |
Recruitment Status :
Recruiting
First Posted : December 11, 2019
Last Update Posted : February 8, 2021
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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.
Condition or disease |
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HIV/AIDS |
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.
Study Type : | Observational |
Estimated Enrollment : | 500 participants |
Observational Model: | Cohort |
Time Perspective: | Retrospective |
Official Title: | Demographic, Clinical, and Laboratory Characteristics and Outcomes of Patients Who Ever Received Etravirine and/or Darunavir - Multi-country Data Abstraction |
Actual Study Start Date : | January 1, 2019 |
Estimated Primary Completion Date : | December 31, 2021 |
Estimated Study Completion Date : | December 31, 2022 |

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

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Ages Eligible for Study: | up to 25 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04194021
Contact: Appolinaire Tiam, MBChB, MMed | 202-296-9165 | atiam@pedaids.org | |
Contact: Natella Rakhmanina, MD, PhD | 202.296.9165 | nrakhmanina@pedaids.org |
Cameroon | |
Elizabeth Glaser Pediatric AIDS Foundation/Cameroon | Not yet recruiting |
Yaounde, Centre Region, Cameroon | |
Contact: Boris Tchounga btchounga@pedaids.org | |
Principal Investigator: Boris Tchounga | |
Kenya | |
Elizabeth Glaser Pediatric AIDS Foundation/Kenya | Recruiting |
Nairobi, Kenya | |
Contact: Rose Masaba rmasaba@pedaids.org | |
Principal Investigator: Rose Masaba | |
Lesotho | |
Elizabeth Glaser Pediatric AIDS Foundation/Lesotho | Recruiting |
Maseru, Lesotho | |
Contact: Vincent Tukei vtukei@pedaids.org | |
Principal Investigator: Vincent Tukei | |
Swaziland | |
Elizabeth Glaser Pediatric AIDS Foundation/Eswatini | Recruiting |
Mbabane, Hhohho, Swaziland | |
Contact: Philisiwe Khumalo pkhumalo@pedaids.org | |
Principal Investigator: Philisiwe Khumalo | |
Uganda | |
Elizabeth Glaser Pediatric AIDS Foundation/Uganda | Recruiting |
Mbarara, Uganda | |
Contact: Racheal Tumwebaze rtumwebaze@pedaids.org | |
Sub-Investigator: Racheal Tumwebaze |
Principal Investigator: | Appolinaire Tiam, MBChB, MMed | Elizabeth Glaser Pediatric AIDS Foundation |
Documents provided by Elizabeth Glaser Pediatric AIDS Foundation:
Responsible Party: | Elizabeth Glaser Pediatric AIDS Foundation |
ClinicalTrials.gov Identifier: | NCT04194021 |
Other Study ID Numbers: |
EG0205 |
First Posted: | December 11, 2019 Key Record Dates |
Last Update Posted: | February 8, 2021 |
Last Verified: | February 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | Yes |
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 |
Acquired Immunodeficiency Syndrome HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases |
Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Slow Virus Diseases Immunologic Deficiency Syndromes Immune System Diseases |