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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

Tracking Information
First Submitted Date December 9, 2019
First Posted Date December 11, 2019
Last Update Posted Date February 8, 2021
Actual Study Start Date January 1, 2019
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 9, 2019)
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
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: December 9, 2019)
  • 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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Characteristics and Outcomes of Patients Who Received Etravirine and/or Darunavir
Official Title Demographic, Clinical, and Laboratory Characteristics and Outcomes of Patients Who Ever Received Etravirine and/or Darunavir - Multi-country Data Abstraction
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.
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
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition HIV/AIDS
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: December 9, 2019)
500
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 31, 2022
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages up to 25 Years   (Child, Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Appolinaire Tiam, MBChB, MMed 202-296-9165 atiam@pedaids.org
Contact: Natella Rakhmanina, MD, PhD 202.296.9165 nrakhmanina@pedaids.org
Listed Location Countries Cameroon,   Kenya,   Lesotho,   Swaziland,   Uganda
Removed Location Countries  
 
Administrative Information
NCT Number NCT04194021
Other Study ID Numbers EG0205
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Elizabeth Glaser Pediatric AIDS Foundation
Study Sponsor Elizabeth Glaser Pediatric AIDS Foundation
Collaborators Janssen, LP
Investigators
Principal Investigator: Appolinaire Tiam, MBChB, MMed Elizabeth Glaser Pediatric AIDS Foundation
PRS Account Elizabeth Glaser Pediatric AIDS Foundation
Verification Date February 2021