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

NCT04194021 | Unknown

• 1 other identifier: EG0205
• Study Type: observational
• Target: 871
• Locations: 5 countries
• Sites: 5

Brief Summary

The objectives of this data collection activity are to:

1. 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. 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. 3.Describe dynamics in HIV drug resistance mutations among patients who fail treatment on new regimens including DRV and/or ETR;
4. 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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Demographic profile of patients who ever received darunavir and/or etravirine

  At initiation of darunavir and/or etravirine

• Dynamics in HIV drug resistance mutations

  At initiation of darunavir and/or etravirine, thereafter every six months to the end of 2021, 12 months after turning age 25

Eligibility Criteria

• Age: Up to 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Above age 25.
• Residing in a country not participating in the New Horizons Collaborative.

Sponsors & Collaborators

• Elizabeth Glaser Pediatric AIDS Foundation: lead
• Janssen, LP: collaborator

Study Sites (5)

Elizabeth Glaser Pediatric AIDS Foundation/Cameroon

Yaoundé, Centre Region, Cameroon

Location

Elizabeth Glaser Pediatric AIDS Foundation/Eswatini

Mbabane, Hhohho Region, Eswatini

Location

Elizabeth Glaser Pediatric AIDS Foundation/Kenya

Nairobi, Kenya

Location

Elizabeth Glaser Pediatric AIDS Foundation/Lesotho

Maseru, Lesotho

Location

Elizabeth Glaser Pediatric AIDS Foundation/Uganda

Mbarara, Uganda

Location

Related Publications (14)

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• 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.

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• 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.

  PMID: 17367540 BACKGROUND

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  PMID: 17620753 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.

  PMID: 17954553 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.

  PMID: 19812449 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.

  PMID: 21041921 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.

  PMID: 21172789 BACKGROUND

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  PMID: 22293546 BACKGROUND

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MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Appolinaire Tiam, MBChB, MMed

  Elizabeth Glaser Pediatric AIDS Foundation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2019
• First Posted: December 11, 2019
• Study Start: January 1, 2019
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2023
• Last Updated: April 18, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

KE (1); ES (1); CA (1); LE (1); UG (1)