Title of Study: A Phase IIIB/IV Randomized Open-label Trial Comparing Dolutegravir with Predetermined Nucleosides Versus Recommended Standard of Care ART R regimens in Patients with HIV-1 Infection Failing First Line Therapy

Subtitle: D2EFT: Dolutegravir and Darunavir Evaluation in Adults Failing Therapy

Protocol; Version: NCT03017872; Version 2.0

Phase of Study: Phase 3;

Study Type: grant aided study

Approval Date:

Applicant Name: The Institute of Human Virology-IHVN

Address: Pent House, Maina Court, Plot 252, Herbert Macauly Way, CDB, Garki Way, Abuja

Date of Application: 2019-03-20

Applicant Name: The Institute of Human Virology-IHVN

Sponsor: University of New South Wales

Address of Sponsor: The Kirby Institute, University of New South Wales

Trial Sites: 1. University of Abuja Teaching Hospital, Gwagwalada, Area Council, Abuja 2. National Hospital Abuja, 265 Independence Avenue, CBD, Abuja

Product Type: Drug

Status of Approval: On-going