Characteristics and Outcomes of Patients Who Received Etravirine and/or Darunavir (NewHorizon)

April 17, 2023 updated by: Elizabeth Glaser Pediatric AIDS Foundation

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Detailed Description

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

Enrollment (Actual)

871

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Cameroon
    • Centre Region
      • Yaounde, Centre Region, Cameroon
        • Elizabeth Glaser Pediatric AIDS Foundation/Cameroon
  • Kenya
      • Nairobi, Kenya
        • Elizabeth Glaser Pediatric AIDS Foundation/Kenya
  • Lesotho
      • Maseru, Lesotho
        • Elizabeth Glaser Pediatric AIDS Foundation/Lesotho
  • Swaziland
    • Hhohho
      • Mbabane, Hhohho, Swaziland
        • Elizabeth Glaser Pediatric AIDS Foundation/Eswatini
  • Uganda
      • Mbarara, Uganda
        • Elizabeth Glaser Pediatric AIDS Foundation/Uganda

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 25 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
Time Frame: At initiation of 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
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
At initiation of darunavir and/or etravirine, thereafter every six months to the end of 2021, 12 months after turning age 25

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Elizabeth Glaser Pediatric AIDS Foundation

Collaborators

Janssen, LP

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2019

Primary Completion (Actual)

December 31, 2022

Study Completion (Anticipated)

December 31, 2023

Study Registration Dates

First Submitted

December 9, 2019

First Submitted That Met QC Criteria

December 9, 2019

First Posted (Actual)

December 11, 2019

Study Record Updates

Last Update Posted (Actual)

April 18, 2023

Last Update Submitted That Met QC Criteria

April 17, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EG0205

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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