Characteristics and Outcomes of Patients Who Received Etravirine and/or Darunavir
NCT ID: NCT04194021
Last Updated: 2023-04-18
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
UNKNOWN
Total Enrollment
871 participants
Study Classification
OBSERVATIONAL
Study Start Date
2019-01-01
Study Completion Date
2023-12-31
Brief Summary
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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.
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.
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Detailed Description
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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.
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.
Conditions
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HIV/AIDS
Study Design
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Observational Model Type
COHORT
Study Time Perspective
RETROSPECTIVE
Eligibility Criteria
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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.
* 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.
* Residing in a country not participating in the New Horizons Collaborative.
Maximum Eligible Age
25 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
Yes
Sponsors
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Janssen, LP
INDUSTRY
Sponsor Role
collaborator
Elizabeth Glaser Pediatric AIDS Foundation
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Appolinaire Tiam, MBChB, MMed
Role: PRINCIPAL_INVESTIGATOR
Elizabeth Glaser Pediatric AIDS Foundation
Locations
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Elizabeth Glaser Pediatric AIDS Foundation/Cameroon
Yaoundé, Centre Region, Cameroon
Site Status
Elizabeth Glaser Pediatric AIDS Foundation/Eswatini
Mbabane, Hhohho Region, Eswatini
Site Status
Elizabeth Glaser Pediatric AIDS Foundation/Kenya
Nairobi, , Kenya
Site Status
Elizabeth Glaser Pediatric AIDS Foundation/Lesotho
Maseru, , Lesotho
Site Status
Elizabeth Glaser Pediatric AIDS Foundation/Uganda
Mbarara, , Uganda
Site Status
Countries
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Cameroon
Eswatini
Kenya
Lesotho
Uganda
References
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Clavel F, Hance AJ. HIV drug resistance. N Engl J Med. 2004 Mar 4;350(10):1023-35. doi: 10.1056/NEJMra025195. No abstract available.
Reference Type
BACKGROUND
Petersen ML, van der Laan MJ, Napravnik S, Eron JJ, Moore RD, Deeks SG. Long-term consequences of the delay between virologic failure of highly active antiretroviral therapy and regimen modification. AIDS. 2008 Oct 18;22(16):2097-106. doi: 10.1097/QAD.0b013e32830f97e2.
Reference Type
BACKGROUND
Vaz P, Augusto O, Bila D, Macassa E, Vubil A, Jani IV, Pillon R, Sandstrom P, Sutherland D, Giaquinto C, Jordan MR, Bertagnolio S. Surveillance of HIV drug resistance in children receiving antiretroviral therapy: a pilot study of the World Health Organization's generic protocol in Maputo, Mozambique. Clin Infect Dis. 2012 May;54 Suppl 4(Suppl 4):S369-74. doi: 10.1093/cid/cis006.
Reference Type
BACKGROUND
Puthanakit T, Aurpibul L, Oberdorfer P, Akarathum N, Kanjanavanit S, Wannarit P, Sirisanthana T, Sirisanthana V. Sustained immunologic and virologic efficacy after four years of highly active antiretroviral therapy in human immunodeficiency virus infected children in Thailand. Pediatr Infect Dis J. 2007 Oct;26(10):953-6. doi: 10.1097/INF.0b013e318125720a.
Reference Type
BACKGROUND
Bolton-Moore C, Mubiana-Mbewe M, Cantrell RA, Chintu N, Stringer EM, Chi BH, Sinkala M, Kankasa C, Wilson CM, Wilfert CM, Mwango A, Levy J, Abrams EJ, Bulterys M, Stringer JS. Clinical outcomes and CD4 cell response in children receiving antiretroviral therapy at primary health care facilities in Zambia. JAMA. 2007 Oct 24;298(16):1888-99. doi: 10.1001/jama.298.16.1888.
Reference Type
BACKGROUND
Sutcliffe CG, van Dijk JH, Bolton C, Persaud D, Moss WJ. Effectiveness of antiretroviral therapy among HIV-infected children in sub-Saharan Africa. Lancet Infect Dis. 2008 Aug;8(8):477-89. doi: 10.1016/S1473-3099(08)70180-4.
Reference Type
BACKGROUND
Reddi A, Leeper SC, Grobler AC, Geddes R, France KH, Dorse GL, Vlok WJ, Mntambo M, Thomas M, Nixon K, Holst HL, Karim QA, Rollins NC, Coovadia HM, Giddy J. Preliminary outcomes of a paediatric highly active antiretroviral therapy cohort from KwaZulu-Natal, South Africa. BMC Pediatr. 2007 Mar 17;7:13. doi: 10.1186/1471-2431-7-13.
Reference Type
BACKGROUND
Katabira ET, Oelrichs RB. Scaling up antiretroviral treatment in resource-limited settings: successes and challenges. AIDS. 2007 Jul;21 Suppl 4:S5-10. doi: 10.1097/01.aids.0000279701.93932.ef. No abstract available.
Reference Type
BACKGROUND
Janssens B, Raleigh B, Soeung S, Akao K, Te V, Gupta J, Vun MC, Ford N, Nouhin J, Nerrienet E. Effectiveness of highly active antiretroviral therapy in HIV-positive children: evaluation at 12 months in a routine program in Cambodia. Pediatrics. 2007 Nov;120(5):e1134-40. doi: 10.1542/peds.2006-3503. Epub 2007 Oct 22.
Reference Type
BACKGROUND
Arasteh K, Yeni P, Pozniak A, Grinsztejn B, Jayaweera D, Roberts A, Hoy J, De Meyer S, Vangeneugden T, Tomaka F. Efficacy and safety of darunavir/ritonavir in treatment-experienced HIV type-1 patients in the POWER 1, 2 and 3 trials at week 96. Antivir Ther. 2009;14(6):859-64. doi: 10.3851/IMP1301.
Reference Type
BACKGROUND
Katlama C, Clotet B, Mills A, Trottier B, Molina JM, Grinsztejn B, Towner W, Haubrich R, Nijs S, Vingerhoets J, Woodfall B, Witek J. Efficacy and safety of etravirine at week 96 in treatment-experienced HIV type-1-infected patients in the DUET-1 and DUET-2 trials. Antivir Ther. 2010;15(7):1045-52. doi: 10.3851/IMP1662.
Reference Type
BACKGROUND
Imaz A, Llibre JM, Mora M, Mateo G, Camacho A, Blanco JR, Curran A, Santos JR, Caballero E, Bravo I, Gaya F, Domingo P, Rivero A, Falco V, Clotet B, Ribera E. Efficacy and safety of nucleoside reverse transcriptase inhibitor-sparing salvage therapy for multidrug-resistant HIV-1 infection based on new-class and new-generation antiretrovirals. J Antimicrob Chemother. 2011 Feb;66(2):358-62. doi: 10.1093/jac/dkq432. Epub 2010 Dec 14.
Reference Type
BACKGROUND
Fagard C, Colin C, Charpentier C, Rami A, Jacomet C, Yeni P, Vittecoq D, Katlama C, Molina JM, Descamps D, Chene G, Yazdanpanah Y; ANRS 139 TRIO Trial Group. Long-term efficacy and safety of raltegravir, etravirine, and darunavir/ritonavir in treatment-experienced patients: week 96 results from the ANRS 139 TRIO trial. J Acquir Immune Defic Syndr. 2012 Apr 15;59(5):489-93. doi: 10.1097/QAI.0b013e31824bb720.
Reference Type
BACKGROUND
Corrigan B, Mukui I, Mulenga L, Mthethwa N, Letsie M, Bruno S, Rakhmanina N. Characteristics of Treatment-experienced HIV-infected African Children and Adolescents Initiating Darunavir and/or Etravirine-based Antiretroviral Treatment. Pediatr Infect Dis J. 2018 Jul;37(7):669-672. doi: 10.1097/INF.0000000000001843.
Reference Type
BACKGROUND
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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EG0205
Identifier Type: -
Identifier Source: org_study_id
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