NCT03988452: NADIA

Nucleosides And Darunavir/Dolutegravir In Africa

Status unknown Phase 3 Last updated 30 July 2020

What this trial tests

Phase 3 trial testing Darunavir in Human Immunodeficiency Virus in 465 participants. Status unknown.

Timeline

30 July 2019

Primary endpoint
30 September 2020

30 September 2021

Quick facts

Lead sponsor	Makerere University
Phase	Phase 3
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	factorial
Masking	none
Primary purpose	treatment
Enrollment	465
Start date	30 July 2019
Primary completion	30 September 2020
Estimated completion	30 September 2021
Sites	1 location across Uganda

Drugs / interventions tested

• Darunavir (DARUNAVIR) — full drug profile →
• Ritonavir (ritonavir) — full drug profile →
• Dolutegravir (DOLUTEGRAVIR) — full drug profile →
• Zidovudine (ZIDOVUDINE) — full drug profile →
• Tenofovir
• Lamivudine (LAMIVUDINE) — full drug profile →

Conditions studied

• Human Immunodeficiency Virus — all drugs for Human Immunodeficiency Virus →

Sponsor

Makerere University

Who can join

12 and older, any sex, with Human Immunodeficiency Virus. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This trial evaluates options for second-line antiretroviral therapy in patients failing on a non-nucleoside reverse transcriptase inhibitor (NNRTI) and tenofovir (TDF)-based first-line regimen in the setting of the public health approach in sub-Saharan Africa (with assumed substantial nucleoside reverse transcriptase inhibitor (NRTI) cross-resistance). The trial tests two hypotheses. Firstly that a regimen of dolutegravir (DTG) with two NRTIs is non-inferior to a regimen of ritonavir-boosted darunavir (DRV/r) with two NRTIs. Secondly that continuing an NRTI regimen of TDF and lamivudine (3TC) is non-inferior to switching to zidovudine (ZDV) and 3TC.

The trial is a parallel group, open-label, multi-centre, factorial (2X2) randomised, controlled trial. Patients will be randomised to either DTG or DRV/r with a second randomisation to ZDV and 3TC or TDF and 3TC. Treatment efficacy will be monitored by testing viral load (VL). Analyses will compare DRV/r with DTG; and ZDV/3TC with TDF/3TC by intention to treat analysis on the primary outcome parameter of plasma VL below 400 copies/ml at 48 weeks. Trial follow-up will continue to 96 weeks.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Dolutegravir or Darunavir in Combination with Zidovudine or Tenofovir to Treat HIV.
   Paton NI, Musaazi J, Kityo C, Walimbwa S, et al · · 2021 · cited 132× · PMID 34289276 · DOI 10.1056/nejmoa2101609
2. Efficacy and safety of dolutegravir or darunavir in combination with lamivudine plus either zidovudine or tenofovir for second-line treatment of HIV infection (NADIA): week 96 results from a prospective, multicentre, open-label, factorial, randomised, non-inferiority trial.
   Paton NI, Musaazi J, Kityo C, Walimbwa S, et al · · 2022 · cited 108× · PMID 35460601 · DOI 10.1016/s2352-3018(22)00092-3