Clinical trial NCT04194021: 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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: HIV/AIDS
Keywords: 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
Lead sponsor: Elizabeth Glaser Pediatric AIDS Foundation
Sponsor class: OTHER
Collaborators: name: Janssen, LP
First posted: 2019-12-11
Enrollment: 871
Sex: ALL
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.

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.

Primary outcomes:
measure: Clinical profile of patients who ever received darunavir and/or etravirine
timeFrame: At initiation of darunavir and/or etravirine, thereafter every six months to the end of 2021, 12 months after turning age 25
Secondary outcomes:
measure: Demographic profile of patients who ever received darunavir and/or etravirine
timeFrame: At initiation of darunavir and/or etravirine
measure: Dynamics in HIV drug resistance mutations
timeFrame: At initiation of darunavir and/or etravirine, thereafter every six months to the end of 2021, 12 months after turning age 25
Other outcomes:
Locations:
city: Yaounde
country: Cameroon
facility: Elizabeth Glaser Pediatric AIDS Foundation/Cameroon
state: Centre Region
city: Nairobi
country: Kenya
facility: Elizabeth Glaser Pediatric AIDS Foundation/Kenya
city: Maseru
country: Lesotho
facility: Elizabeth Glaser Pediatric AIDS Foundation/Lesotho
city: Mbabane
country: Swaziland
facility: Elizabeth Glaser Pediatric AIDS Foundation/Eswatini
state: Hhohho
city: Mbarara
country: Uganda
facility: Elizabeth Glaser Pediatric AIDS Foundation/Uganda
Study officials:
affiliation: Elizabeth Glaser Pediatric AIDS Foundation
name: Appolinaire Tiam, MBChB, MMed
role: PRINCIPAL_INVESTIGATOR
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