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KK-1439-066

A Phase 2 Clinical Study to Evaluate the Pharmacokinetics, Safety, and Efficacy of Doravirine and Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate in Participants With HIV-1, who are 4 Weeks to less than 12 Years of Age and Weigh less than 45 kg.

Rationale

As in adults, the objective of ART in the pediatric population is to achieve and/or maintain suppression of HIV-1 RNA. Sustained virologic suppression preserves/restores immunologic function, inhibits the emergence of drug resistance, and ultimately decreases morbidity and mortality [Panel on Antiretroviral Guidelines for Adults and Adolescents 2018]. Virologic suppression of HIV-1 RNA is even more important in infants and young children because, if left untreated, progression to AIDS and death occurs more rapidly than in adults [Tovo, P. A., et al 1992] [Diaz, C., et al 1998] [HIV Paediatric Prognostic Markers Collaborative Study Group 2003] [Newell, M. L., et al 2004].

Additionally, the advent of cART has dramatically improved neurocognitive development in infants and children with HIV-1, and virtually eliminated HIV encephalopathy among perinatally-infected children [Laughton, B., et al 2018] [Patel, K., et al 2009]. First-line therapy with NNRTIs or switching to NNRTIs while suppressed on ART has proven to be effective for infants, children, and adolescents infected with HIV-1 [Food and Drug Administration 2019]. As infants and children with HIV represent a particularly vulnerable population, development of antiretrovirals that are well tolerated, potent, with a simple once-daily dose regimen continues to be a priority [Food and Drug Administration 2019] [AIDS Free Working Group 2018]. This protocol will assess the PK, safety, and efficacy of an age-appropriate formulation of DOR used in combination with 2 NRTIs or as an FDC of DOR/3TC/TDF in pediatric participants with HIV-1 aged 4 weeks.

Investigators

  • Prof Lee Fairlie, Principal Investigator
  • Dr Faeezah Patel, Sub investigator
  • Dr Elizea Horne, Sub Investigator.
  • Dr Rob Keiser, Sub Investigator
  • Dr Mrinmayee Dhar

Latest Update

March 2024

For more about KK-1439-066 study please email rhicomms@wrhi.ac.za

Research and Policy Briefs

KK-1439-066

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