Skip to main content
OpenTrials
Completed

NCT Number: NCT04194021

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

The objectives of this data collection activity are to:

1. 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; 2. 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; 3. Describe dynamics in HIV drug resistance mutations among patients who fail treatment on new regimens including DRV and/or ETR; 4. 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

HIV/AIDS Acquired Immunodeficiency Syndrome Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

Up to 25 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Elizabeth Glaser Pediatric AIDS Foundation/Cameroon, Yaoundé, Centre Region, Cameroon

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

Elizabeth Glaser Pediatric AIDS Foundation

Other

Collaborators

  • Janssen, LP

Registry information

Official study title

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

Acronym: NewHorizon

Important dates

Study start
2019
Primary completion
2022
Study completion
2023
First posted
Dec 11, 2019
Registry last updated
Sep 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.