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

• ClinicalTrials.gov Identifier: NCT04194021
• Recruitment Status: Recruiting
• First Posted: December 11, 2019
• Last Update Posted: February 8, 2021
• Sponsor: Elizabeth Glaser Pediatric AIDS Foundation
• 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

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 *

• Clavel F, Hance AJ. HIV drug resistance. N Engl J Med. 2004 Mar 4;350(10):1023-35.
• 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.
• 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:S369-74. doi: 10.1093/cid/cis006.
• 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.
• 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.
• 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. Review. Erratum in: Lancet Infect Dis. 2009 Dec;9(12):736.
• 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.
• Katabira ET, Oelrichs RB. Scaling up antiretroviral treatment in resource-limited settings: successes and challenges. AIDS. 2007 Jul;21 Suppl 4:S5-10. Review.
• 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. Epub 2007 Oct 22.
• Arastéh 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.
• 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.
• Imaz A, Llibre JM, Mora M, Mateo G, Camacho A, Blanco JR, Curran A, Santos JR, Caballero E, Bravo I, Gayá F, Domingo P, Rivero A, Falcó 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. Erratum in: J Antimicrob Chemother. 2011 Sep;66(9):2194.
• Fagard C, Colin C, Charpentier C, Rami A, Jacomet C, Yeni P, Vittecoq D, Katlama C, Molina JM, Descamps D, Chêne 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.
• 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.

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

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