D2EFT
D2EFT : Dolutegravir and Darunavir Evaluation in adults Failing Therapy
ClinicalTrials.gov: NCT03017872
Collaborator: UNSW (Kirby Institute)
Status: Completed
The D²EFT study was an international randomized open-label non-inferiority phase IIIB/IV trial that compared novel second-line antiretroviral therapy regimens to standard of care in adult HIV-1 patients failing first-line antiretroviral therapy. The study enrolled 831 participants globally (46 from Indonesia) between November 2017 and December 2022. Once randomized, participants were seen at study weeks 0, 4, 24, 48, and 96 to obtain clinical data and blood specimens for various tests, including CD4+ cell counts, HIV plasma viral loads, and resistance genotyping. The study found that all three antiretroviral treatment regimens tested (darunavir/ritonavir + 2NRTIs, dolutegravir + darunavir/ritonavir, and dolutegravir + tenofovir + lamivudine or emtricitabine) provided high virological efficacy (76%–86%), although the dolutegravir combinations were superior to standard darunavir/ritonavir + 2NRTIs.
Associated Publications:
- Dolutegravir plus boosted darunavir versus recommended standard-of-care antiretroviral regimens in people with HIV-1 for whom recommended first-line non-nucleoside reverse transcriptase inhibitor therapy has failed (D2EFT): an open-label, randomised, phase 3b/4 trial. Lancet HIV. 2024 Jul;11(7):e436-e448. doi: 10.1016/S2352-3018(24)00089-4. Epub 2024 May 21. PMID: 38788744.
- Adaption of an ongoing clinical trial to quickly respond to gaps in changing international recommendations: the experience of D2EFT. HIV Res Clin Pract. 2022 Jul 19;23(1):37-46. PMID: 35938597.
- A randomised trial to compare dolutegravir plus boosted darunavir versus recommended standard of care antiretroviral regimens in people with HIV-1, whose first-line non-nucleoside reverse transcriptase inhibitor therapy has failed: Final 96-week results of the D2EFT study. Clin Infect Dis. 2025 Jun 27:ciaf346. doi: 10.1093/cid/ciaf346. Epub ahead of print. PMID: 40577173.
Associated Biorepository
| Specimen Type | Baseline | Week 4 | Week 24 | Week 48 | Week 96 |
| Plasma | 46 | 46 | 1 | 45 | 46 |
| Buffy Coat | 46 | N/A | N/A | N/A | N/A |
| Serum | 46 | N/A | N/A | 45 | 46 |
| Specimen type | Visit | Subtype | |||
| B/CRF01_AE | CRF01_AE | PR: D; RT: B | PR+RT: B; RT+IN: AE | ||
| Plasma | Baseline | 1 | 38 | 1 | 1 |
| W4 | 1 | 38 | 1 | 1 | |
| W24 | 1 | N/A | N/A | N/A | |
| W48 | 1 | 37 | 1 | 1 | |
| W96 | 1 | 38 | 1 | 1 | |
| Serum | Baseline | 1 | 38 | 1 | 1 |
| W48 | 1 | 37 | 1 | 1 | |
| W96 | 1 | 38 | 1 | 1 | |
| Buffy Coat | Baseline | 1 | 38 | 1 | 1 |