NCT03988452

Nucleosides And Darunavir/Dolutegravir In Africa

Nucleosides And Darunavir/Dolutegravir In Africa (NADIA): a Randomised Controlled Trial of Darunavir Versus Dolutegravir and Tenofovir Versus Zidovudine in Second-line Antiretroviral Therapy Regimens for the Public Health Approach in Sub-Saharan Africa

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 465 (actual)
• Sponsor: Makerere University · Academic / Other
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Human Immunodeficiency Virus

Interventions

Type	Name	Description
DRUG	Darunavir	Antiretroviral therapy
DRUG	Ritonavir	Antiretroviral therapy
DRUG	Dolutegravir	Antiretroviral therapy
DRUG	Zidovudine	Antiretroviral therapy
DRUG	Tenofovir	Antiretroviral therapy
DRUG	Lamivudine	Antiretroviral therapy

Timeline

• Start date: 2019-07-30
• Primary completion: 2020-09-30
• Completion: 2021-09-30
• First posted: 2019-06-17
• Last updated: 2020-07-30

Locations

1 site across 1 country: Uganda