10. Set up a clinical study to determine in young children co-infected with HIV and TB to determine if dose adjustments are needed when the 4-in1 is used with a rifampicin-containing regimen. 

11. Facilitate a clinical study to determine safe and efficacious dosage of the 4-in-1 in neonates. 

58. Support MOHs to accelerate the introduction and roll out of optimized formulations in at least 6 countries: Kenya, Uganda, Tanzania, Senegal, Burkina Faso and Cameroon.

63. Work with ARV Procurement Working Group to ensure coordination of demand and supply of 4-in-1 and LPV/r pellets.


25. DNDi commits to continue supporting efforts to improve sustainable in-country access to 2-in-1 LPV/r by providing technical support on use of LPV/r pellets and granules through collaboration with Unitaid, APWG, other GAP-f partners, PEPFAR, MoHs, and HIV stakeholders in country.

26. DNDi, ICAP, and EGPAF commit to collaborate on product uptake for solid oral dosage forms of
LPV/r (2-in-1’s and 4-in-1), including:

  • Development of healthcare workers’ training tools based on implementation research data generated by DNDi; and

  • Acceleration of product uptake in selected countries with engagement of all stakeholders including MOH, civil society, FBOs, and communities of people living with HIV, and to share the training toolkit and experience by disseminating information globally.

Commitment 25:


June 2020

LPV/r uptake:

  • DNDi has worked with Baylor’s College in Malawi to adapt video of administration of pellets to local context, in local language (chichewe), for wide dissemination by mobile phone. Malawi is now transitioning to LPV/r granules.

  • DNDi provided support to the introduction of LPV/r granules in Tanzania via collaboration with EGPAF where 40 sites have been trained and remaining 62 sites to be supported in 2020.

  • DNDi worked with Ministry of Health Ethiopia to adapt video of administration of pellets to local context, in local language (Amharic), for wide dissemination by mobile phone.

  • DNDi provided support on training tools and training for South African Health care workers on LPV/r pellets.

Commitment 26:. 


June 2020

4-in-1 development:

  • Two 4-in-1 relative bioavailability studies in adult healthy volunteers, required for USFDA filing of the 4-in-1, started in May 2019 and were completed in July 2019. Application currently under FDA review.

  • A study with 4-in-1 in children living with HIV weighing ≥3 and <25 kg is ongoing in Uganda to assess the pharmacokinetics, safety and acceptability of the new. The study should complete by early 2021.

  • DNDi is working with Stellenbosch University (Cape Town, South Africa) and Cipla to set-up the PETITE study in South Africa; this study aims to assess the pharmacokinetics of the 4-in-1 in the neonatal population. The recruitment will start in September 2020.

  • DNDi is collaborating with EGPAF, ICAP and EVA in 6 countries (Kenya, Uganda, Tanzania, Senegal, Burkina Faso and Cameroun)  in supporting the uptake of the LPV/r heat-stable formulations in country and to ensure smooth and rapid transition from 2-in-1 to 4-in-1 when 4-in-1 receives USFDA tentative approval.