• DNDi_Logo_No-Tagline_Full Colour
  • Our work
    • Diseases
      • Sleeping sickness
      • Visceral leishmaniasis
      • Cutaneous leishmaniasis
      • Chagas disease
      • Filaria: river blindness
      • Mycetoma
      • Paediatric HIV
      • Cryptococcal meningitis
      • Hepatitis C
      • Dengue
      • Pandemic preparedness
      • Antimicrobial resistance
    • Research & development
      • R&D portfolio & list of projects
      • Drug discovery
      • Translational research
      • Clinical trials
      • Registration & access
      • Treatments delivered
    • Advocacy
      • Open and collaborative R&D
      • Transparency of R&D costs
      • Pro-access policies and IP
      • Children’s health
      • Gender equity
      • Climate change
      • AI and new technologies
  • Networks & partners
    • Partnerships
      • Our partners
      • Partnering with us
    • Global networks
      • Chagas Platform
      • Dengue Alliance
      • HAT Platform
      • LEAP Platform
      • redeLEISH Network
    • DNDi worldwide
      • DNDi Switzerland
      • DNDi DRC
      • DNDi Eastern Africa
      • DNDi Japan
      • DNDi Latin America
      • DNDi North America
      • DNDi South Asia
      • DNDi South-East Asia
  • News & resources
    • News & stories
      • News
      • Stories
      • Statements
      • Viewpoints
      • Social media
      • eNews Newsletter
    • Press
      • Press releases
      • In the media
      • Podcasts, radio & TV
      • Media workshops
    • Resources
      • Scientific articles
      • Our publications
      • Videos
    • Events
  • About us
    • About
      • Who we are
      • How we work
      • Our strategy
      • Our donors
      • Annual reports
      • Our prizes and awards
      • Our story: 20 years of DNDi
    • Our people
      • Our leadership
      • Our governance
      • Contact us
    • Work with us
      • Working at DNDi
      • Job opportunities
      • Requests for proposal
  • Donate
  • DNDi_Logo_No-Tagline_Full Colour
  • Our work
    • Diseases
      • Sleeping sickness
      • Visceral leishmaniasis
      • Cutaneous leishmaniasis
      • Chagas disease
      • Filaria: river blindness
      • Mycetoma
      • Paediatric HIV
      • Cryptococcal meningitis
      • Hepatitis C
      • Dengue
      • Pandemic preparedness
      • Antimicrobial resistance
    • Research & development
      • R&D portfolio & list of projects
      • Drug discovery
      • Translational research
      • Clinical trials
      • Registration & access
      • Treatments delivered
    • Advocacy
      • Open and collaborative R&D
      • Transparency of R&D costs
      • Pro-access policies and IP
      • Children’s health
      • Gender equity
      • Climate change
      • AI and new technologies
  • Networks & partners
    • Partnerships
      • Our partners
      • Partnering with us
    • Global networks
      • Chagas Platform
      • Dengue Alliance
      • HAT Platform
      • LEAP Platform
      • redeLEISH Network
    • DNDi worldwide
      • DNDi Switzerland
      • DNDi DRC
      • DNDi Eastern Africa
      • DNDi Japan
      • DNDi Latin America
      • DNDi North America
      • DNDi South Asia
      • DNDi South-East Asia
  • News & resources
    • News & stories
      • News
      • Stories
      • Statements
      • Viewpoints
      • Social media
      • eNews Newsletter
    • Press
      • Press releases
      • In the media
      • Podcasts, radio & TV
      • Media workshops
    • Resources
      • Scientific articles
      • Our publications
      • Videos
    • Events
  • About us
    • About
      • Who we are
      • How we work
      • Our strategy
      • Our donors
      • Annual reports
      • Our prizes and awards
      • Our story: 20 years of DNDi
    • Our people
      • Our leadership
      • Our governance
      • Contact us
    • Work with us
      • Working at DNDi
      • Job opportunities
      • Requests for proposal
  • Donate
Home > News

R&D Portfolio Update March 2018: DNDi Paediatric HIV programme

Home > News

R&D Portfolio Update March 2018: DNDi Paediatric HIV programme

Mother sat on the bed with her son and his medication to treat HIV
15 Mar 2018

DNDi aims to deliver:

  • Two solid taste-masked first-line LPV/r-based fixed-dose formulations in combination with two NRTIs, 3TC plus either ABC or AZT.
  • Immediate introduction of the recently US FDA approved LPV/r-pellets, before the availability of better-adapted 4-in-1 products.

DNDi has made significant progress towards its goal of developing optimal child-adapted antiretroviral (ARV) formulations:

Translation

Translation

One project in the translation phase:

  • Two 4-in-1 LPV/r/ABC/3TC: A first-line “4-in-1” fixed-dose combination (abacavir/lamivudine/lopinavir/ritonavir) is on track to be submitted for registration in late 2018. The combination of protease inhibitors such as lopinavir/ritonavir (LPV/r) with two nucleoside reverse transcriptase inhibitors (abacavir and lamivudine) is considered by the World Health Organization (WHO) as the most effective first-line therapy for infants and children under three years of age. The 4-in-1 will be taste-masked and heat-stable –  a great improvement over the current high-alcohol content LPV/r syrup.In 2017, pharmacokinetic studies in healthy human volunteers were conducted with a final 4-in-1 formulation. Paediatric studies are planned in Uganda and South Africa where the levels of 4-in-1 in children across a large weight range will be measured and compared to the standard treatment. Safety, feasibility, and efficacy data on this new formulation will also be generated to provide evidence for worldwide scale-up.

 

Development

Development

One project in the development phase:

 LPV/r pellets + dual NRTI: In September 2015, DNDi launched the LIVING study with five sites in Kenya to provide early access to LPV/r “oral pellets,” which are taken orally. The study has been expanded to Uganda and Tanzania, and as of November 2017 has enrolled 750 patients. The study is intended to demonstrate the effectiveness, safety, and acceptability of LPV/r oral pellets in the field and pave the way for the 4-in-1.Results were presented at the end of 2017, showing oral pellets are effective, well tolerated and well accepted by caregivers and children. DNDi will support LIVING study sites and other programmes, as well as national governments, to transition from the interim LPV/r oral pellet to the 4-in-1 when it is available.

 

Implementation

Implementation

One project in the implementation phase:

 Superbooster therapy paediatric HIV/TB: The drug rifampicin is the backbone of the regimen to treat tuberculosis (TB) in children. However, rifampicin reduces the bioavailability of protease inhibitors such as LPV/r. This negative drug-drug interaction is a major challenge in treating children infected with both HIV and TB. As part of its development of protease inhibitor-based antiretroviral regimens, DNDi carried out a pharmacokinetic study in 96 infants and young children co-infected with HIV and TB at five sites in South Africa to demonstrate the safety and effectiveness of “super-boosting,” which involves adding extra ritonavir to the LPV/r regimen.The results were presented to the WHO guidelines review committee and have strengthened the WHO recommendation to use super-boosting in TB/HIV co-infected children when they are on a LPV/r-based therapy. This study has been completed and final results were presented in 2017, showing that super-boosting is safe and effective.

 

Photo credit: Scholars & Gentlemen-DNDi

Paediatric HIV

Read, watch, share

Loading...
Press releases
1 Jul 2025

Thailand’s Government Pharmaceutical Organization (GPO) partners with DNDi and Pharco to register an effective and affordable hepatitis C treatment  

Press releases
13 Jun 2025

Serum Institute of India signs a memorandum of understanding (MoU) with DNDi to advance the development of a new treatment for dengue in low- and middle-income countries

Press releases
13 Jun 2025

K-MEDI and DNDi have initiated collaborative R&D to develop a treatment for neglected diseases

News
6 Jun 2025

DNDi is partnering with Médecins Sans Frontières South Asia for the Without Borders Media Fellowship 2025 

News
5 Jun 2025

Meet the DNDi Eastern Africa 2024-2025 Media Fellows

Press releases
5 Jun 2025

Colombia becomes first country to recommend rapid tests to diagnose Chagas disease

Statements
27 May 2025

DNDi interventions at the 78th World Health Assembly

Press releases
22 May 2025

Six African nations commit to eliminate deadly neglected disease visceral leishmaniasis

VIEW ALL

Help neglected patients

To date, we have delivered thirteen new treatments, saving millions of lives.

Our goal is to deliver 25 new treatments in our first 25 years. You can help us get there. 

GIVE NOW
Linkedin-in Instagram Twitter Facebook-f Youtube
International non-profit developing safe, effective, and affordable treatments for the most neglected patients.

Learn more

  • Diseases
  • Neglected tropical diseases
  • R&D portfolio
  • Policy advocacy

Get in touch

  • Our offices
  • Contact us
  • Integrity Line

Support us

  • Donate
  • Subscribe to eNews

Work with us

  • Join research networks
  • Jobs
  • RFPs
  • Terms of Use   
  •   Acceptable Use Policy   
  •   Privacy Policy   
  •   Cookie Policy   
  •   Our policies   

  • Except for images, films and trademarks which are subject to DNDi’s Terms of Use, content on this site is licensed under a Creative Commons Attribution-NonCommercial-Share Alike 3.0 Switzerland License