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Label indication DELSTRIGO ® is indicated as a complete regimen for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 35 kg: with no prior antiretroviral treatment history, OR to replace the current antiretroviral regimen in those who are virologically-suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen with no history of treatment failure and no known substitutions… FDA label
Delstrigo · 1 trial · 1 indication
HIV1-RNA
| Arm | Type | Description |
|---|---|---|
| Treatment Group 1 | EXPERIMENTAL | Delstrigo |
| Treatment Group 2 | OTHER | KOCITAF |
| Name | Type | Description |
|---|---|---|
| Delstrigo | DRUG | Treatment 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. |
| KOCITAF | DRUG | Treatment 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. |
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...
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| Sanofi SA Sponsored ADR | SNY | 1 | PHASE3 | PCV21 |
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| Grifols, S.A. Sponsored ADR Class B | GRFS | 1 | PHASE3 | Xembify |
| CorMedix Inc. | CRMD | 1 | PHASE3 | DefenCath |
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| Novartis AG Sponsored ADR | NVS | 2 | PHASE2 | EDI048 |
| Innoviva, Inc. | INVA | 3 | PHASE2 | Eravacycline, Sulbactam-durlobactam |
| BiomX Inc. | PHGE | 1 | PHASE2 | BX004 |
| Hoffmann-La Roche | RHHBY | 1 | PHASE3 | Baloxavir Marboxil |
| Merck & Co., Inc. | MRK | 2 | PHASE1 | V118C |
| AstraZeneca PLC | AZN | 1 | PHASE1 | AZD7760 |
| BioNTech SE Sponsored ADR | BNTX | 1 | PHASE1 | BNT163 |
| 60 Degrees Pharmaceuticals, Inc. | SXTP | 1 | PHASE2 | Tafenoquine |
| Tarsus Pharmaceuticals, Inc. | TARS | 1 | PHASE2 | TP-05 |
| Moderna, Inc. | MRNA | 1 | PHASE2 | mRNA-1982 |
| AN2 Therapeutics, Inc. | ANTX | 1 | PHASE2 | Epetraborole |
| Emergent BioSolutions Inc. | EBS | 4 | - | AIGIV/kg |
| Phathom Pharmaceuticals, Inc. | PHAT | 1 | - | Vonoprazan |
Delstrigo is a small molecule treatment for HIV-1 infection in adults. It is being studied as a first-line antiretroviral therapy for people starting treatment, and it is given as a complete regimen rather than combined with other HIV medicines.
Delstrigo is developed by Merck & Company, Inc., which trades on the New York Stock Exchange under the ticker MRK. Merck is the sponsor of the clinical program evaluating the drug in HIV-1 infection.
Delstrigo is in Phase 3 clinical development for HIV-1 infection. It is an investigational regimen and is not described as approved. The Phase 3 program is evaluating it in adults beginning first-line antiretroviral therapy.
Delstrigo is being studied in the Phase 3 trial NCT05924438, a randomized, controlled, non-inferiority study comparing DOR/3TC/TDF with DTG/TAF/FTC in participants infected with HIV-1 who are starting first-line antiretroviral therapy. The trial is active and not recruiting, with 600 participants enrolled in South Africa.
NCT05924438 is a randomized, controlled, Phase 3 non-inferiority study with 600 participants. It enrolls adults aged 18 years and older of all sexes in South Africa and compares DOR/3TC/TDF against DTG/TAF/FTC in people with HIV-1 beginning first-line antiretroviral therapy.