A Phase 2 interventional study of Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate 100 MG-300 MG-300 MG Oral Tablet [DELSTRIGO] in Hiv, sponsored by University Hospital, Caen. Recruiting at 4 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-07-24.
Sponsored by University Hospital, Caen · Phase 2, Interventional, and Treatment
The goal of this pilot, phase 2, single-arm, clinical trial is to assess the antiretroviral combination Doravirine (DOR)/Lamivudine (3TC)/Tenofovir Disproxyl Fumarate (TDF) in participants with suppressed HIV who previously developed M184V/I mutation that confers resistance to 3TC. The main question it aims to answer is to explore the rate of HIV suppression 24 weeks after the switch to DOR/3TC/TDF. The study follow-up will continue until 48 weeks. Other endpoints will be metabolic changes, weight changes, modification in the HIV-DNA mutations overtime. Eligible participants will switch from their prior regimen to DOR/3TC/TDF with careful HIV-RNA monitoring.
2,040 studies on the registry are indexed under Acquired Immunodeficiency Syndrome; 272 are open to participants now.
This study's planned enrollment of 32 is below the median of 105 across 1,543 interventional studies indexed under Acquired Immunodeficiency Syndrome.
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Exclusion Criteria:
Doravirine 100 mg Lamivudine 300 mg Tenofovir disoproxil fumarate 245 mg Delstrigo (R): 1 pill/day for 48 weeks
Drug: Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate 100 MG-300 MG-300 MG Oral Tablet [DELSTRIGO]
Switch previous therapy with DOR/TDF/3TC
Also known as: Delstrigo
Plasma HIV-RNA at 24-week
Number of copies/mL
Time frame: 24 weeks from the switch to DOR/3TC/TDF
Plasma HIV-RNA at 48-week
Number of copies/mL
Time frame: 48 weeks from the switch to DOR/3TC/TDF
Plan to share: Yes — Contact principal investigator
Supporting information: Study protocol, Sap, Icf
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Acquired Immunodeficiency Syndrome→
University Hospital, Caen