Characteristics and Outcomes of Patients Who Received Etravirine and/or Darunavir

HIV/AIDS Clinical Trial

— NewHorizon  

Official title:

Demographic, Clinical, and Laboratory Characteristics and Outcomes of Patients Who Ever Received Etravirine and/or Darunavir - Multi-country Data Abstraction

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04194021
• Other study ID #: EG0205
• Status: Active, not recruiting
• Start date: January 1, 2019
• Est. completion date: December 31, 2023

Study information

• Verified date: April 2023
• Source: Elizabeth Glaser Pediatric AIDS Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 871
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 25 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• HIV/AIDS

Locations

Country	Name	City	State
Cameroon	Elizabeth Glaser Pediatric AIDS Foundation/Cameroon	Yaounde	Centre Region
Kenya	Elizabeth Glaser Pediatric AIDS Foundation/Kenya	Nairobi
Lesotho	Elizabeth Glaser Pediatric AIDS Foundation/Lesotho	Maseru
Swaziland	Elizabeth Glaser Pediatric AIDS Foundation/Eswatini	Mbabane	Hhohho
Uganda	Elizabeth Glaser Pediatric AIDS Foundation/Uganda	Mbarara

Sponsors (2)

Lead Sponsor	Collaborator
Elizabeth Glaser Pediatric AIDS Foundation	Janssen, LP

Countries where clinical trial is conducted

Cameroon,  Kenya,  Lesotho,  Swaziland,  Uganda, 

References & Publications (14)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Erratum In: J Antimicrob Chemother. 2011 Sep;66(9):2194. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Erratum In: Lancet Infect Dis. 2009 Dec;9(12):736. — View Citation

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. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical profile of patients who ever received darunavir and/or etravirine	Clinical and laboratory profiles of patients who ever received darunavir and/or etravirine	At initiation of darunavir and/or etravirine, thereafter every six months to the end of 2021, 12 months after turning age 25
Secondary	Demographic profile of patients who ever received darunavir and/or etravirine	Age and gender of patients who ever received darunavir and/or etravirine	At initiation of darunavir and/or etravirine
Secondary	Dynamics in HIV drug resistance mutations	Dynamics in HIV drug resistance mutations among patients who fail treatment	At initiation of darunavir and/or etravirine, thereafter every six months to the end of 2021, 12 months after turning age 25