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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
Sponsor:
Collaborator:
Janssen, LP
Information provided by (Responsible Party):
Elizabeth Glaser Pediatric AIDS Foundation

Brief Summary:

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.

Condition or disease
HIV/AIDS

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.

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
Drug Information available for: Etravirine




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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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
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.
Criteria

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.

Information from the National Library of Medicine

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


Contacts
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Contact: Appolinaire Tiam, MBChB, MMed 202-296-9165 atiam@pedaids.org
Contact: Natella Rakhmanina, MD, PhD 202.296.9165 nrakhmanina@pedaids.org

Locations
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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         
Sponsors and Collaborators
Elizabeth Glaser Pediatric AIDS Foundation
Janssen, LP
Investigators
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Principal Investigator: Appolinaire Tiam, MBChB, MMed Elizabeth Glaser Pediatric AIDS Foundation
  Study Documents (Full-Text)

Documents provided by Elizabeth Glaser Pediatric AIDS Foundation:
Publications:

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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

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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
Keywords provided by Elizabeth Glaser Pediatric AIDS Foundation:
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
Additional relevant MeSH terms:
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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