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Delstrigo

Phase 3

HIV-1-infection | Small molecule | Infectious Disease |Merck & Company, Inc.|Last Updated: Apr 2, 2025

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment600

FDA Designations

No designations recorded

Clinical trial landscape

Delstrigo · 1 trial · 1 indication

Phase 3 1
NCT05924438A Randomised, Phase 3 Non-inferiority Study of DOR/3TC/TDF Compared to DTG/TAF/FTC in Participants Infected With HIV-1 Starting First-line Antiretroviral TherapyHIV-1-infection
ACTIVE NOT_RECRUITING600 Analytics
PHASE3ACTIVE NOT_RECRUITING
A Randomised, Phase 3 Non-inferiority Study of DOR/3TC/TDF Compared to DTG/TAF/FTC in Participants Infected With HIV-1 Starting First-line Antiretroviral Therapy
HIV-1-infectionUnlock trial analytics

Study Endpoints

Primary Endpoints

The antiretroviral activity of DOR/3TC/TDF compared to DTG/TAF/FTC in the first line treatment, as assessed by the percentage of participants with HIV-1 RNA < 50 copies/mL at Week 48
48 Weeks

HIV1-RNA

Secondary Endpoints

The antiretroviral activity of DOR/3TC/TDF compared to DTG/TAF/FTC, as assessed by the percentage of participants with HIV-1 RNA < 50 copies/mL at Week 96
96 Weeks
The antiretroviral activity of DOR/3TC/TDF compared with DTG/TAF/FTC, as assessed by the percentage of participants with HIV-1 RNA <200 copies/mL at Week 48 and Week 96
48 and 96 Weeks
Time to virologic failure (defined as confirmed HIV-1 RNA levels ≥ 1000 copies/mL at week 24 or ≥ 200 copies/mL after week 24)
24 Weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Treatment Group 1EXPERIMENTALDelstrigo
Treatment Group 2OTHERKOCITAF

Interventions

NameTypeDescription
DelstrigoDRUGTreatment Group 1 Participants will receive Doravirine, as part of a fixed-dose oral combination with lamivudine and tenofovir disoproxil fumarate (DOR/3TC/TDF, Delstrigo)tablets which are to be administered orally and once daily.
KOCITAFDRUGTreatment Group 2 Participants will receive dolutegravir, as part of a fixed-dose oral combination with tenofovir alafenamide plus emtricitabine (DTG/TAF/FTC, KOCITAF) tablets which are to be administered orally and once daily.
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Eligibility Criteria

Age Range18 Years to 100 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: Each participant must meet all the following criteria to be enrolled in this study. * ≥18 years old, male or female. * Documented laboratory diagnosis of infection with HIV-1 (positive enzyme-linked immunosorbent assay HIV-1 antibody test) at screening, with no baseline DOR res...

Countries:South Africa
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Frequently asked questions about Delstrigo

What is Delstrigo used for?

Delstrigo is an investigational small molecule being developed for the treatment of HIV-1 infection. It is currently in Phase 3 clinical development as a first-line antiretroviral therapy for adults with HIV-1.

Who makes Delstrigo?

Delstrigo is being developed by Merck & Company, Inc., which trades on the New York Stock Exchange under the ticker symbol MRK. The company is conducting a Phase 3 clinical trial of the drug in South Africa.

What phase is Delstrigo in?

Delstrigo is in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. A Phase 3 non-inferiority study is currently active but not recruiting participants.

What clinical trials is Delstrigo in?

Delstrigo is being studied in a Phase 3 clinical trial with the identifier NCT05924438. This randomized, controlled study is comparing DOR/3TC/TDF to DTG/TAF/FTC in participants with HIV-1 starting first-line antiretroviral therapy. The trial is enrolling 600 participants in South Africa.

Is Delstrigo the same as DOR/3TC/TDF?

Delstrigo is a combination of the drugs doravirine, lamivudine, and tenofovir disoproxil fumarate, which is abbreviated as DOR/3TC/TDF. In the Phase 3 clinical trial, this combination is being compared to another regimen, DTG/TAF/FTC.