Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ART · 1 trial · 1 indication
HIV-1 RNA levels in plasma were measured by polymerase chain reaction (PCR) assay with a reliable lower limit of quantification of \<50 copies/mL. The percentage of participants with HIV-1 RNA ≥50 copies/mL at Week 48 is presented using the FDA Snapshot missing data approach.
An AE is defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants who experienced at least one AE from Day 1 up to Week 48 are reported.
An AE is defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants who experienced at least one AE leading to discontinuation of study intervention from Day 1 up to Week 48 are reported.
| Arm | Type | Description |
|---|---|---|
| DOR/ISL | EXPERIMENTAL | Participants with Human Immunodeficiency Virus-1 (HIV-1) that have been virologically suppressed for ≥3 consecutive months who were previously treated with continuous baseline antiretroviral therapy (ART) receive doravine/islatravir (DOR/ISL), a fixed dose combination (FDC) of 100 mg DOR/0.25 mg ISL orally once daily (qd) for 144 weeks. At Week 144, participants who consent to enter the optional study extension will continue to receive DOR/ISL qd (100 mg/0.25 mg) for an additional 96 weeks or until it is commercially accessible (whichever comes first). |
| ART + DOR/ISL | ACTIVE_COMPARATOR | Participants with HIV-1 that has been virologically suppressed for ≥3 consecutive months who were previously treated with continuous baseline ART received standard of care (SOC) ART for 48 weeks, followed by treatment with DOR/ISL as a FDC of 100 mg DOR/0.25 mg ISL orally qd until Week 144. At Week 144, participants who consent to enter the optional study extension will continue to receive DOR/ISL qd (100 mg/0.25 mg) for an additional 96 weeks or until it is commercially accessible (whichever comes first). |
| Name | Type | Description |
|---|---|---|
| ART | DRUG | Standard of care ART, per approved product list, taken orally |
| DOR/ISL | DRUG | Single tablet combination of 100 mg doravirine (DOR) with 0.25 mg Islatravir (ISL) in tablet form, taken orally, once daily. |
Inclusion Criteria: * Is Human Immunodeficiency Virus-1 (HIV-1) positive with plasma HIV-1 Ribonucleic Acid (RNA) \<50 copies/mL at screening * Has been receiving continuous, stable oral 2-drug or 3-drug combination (± PK booster) antiretroviral therapy ART with documented viral suppression (HIV-1 ...
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ART is a small molecule being developed by Merck & Company, Inc. for the treatment of HIV-1 Infection. It is currently in Phase 3 clinical development as an investigational therapy. The drug is being studied in patients who are virologically suppressed on antiretroviral therapy, with the goal of maintaining viral suppression.
ART is being developed by Merck & Company, Inc., a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol MRK. The company is conducting a Phase 3 clinical trial to evaluate the drug in patients with HIV-1 Infection who are virologically suppressed on antiretroviral therapy.
ART is currently in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The ongoing Phase 3 trial is active but not recruiting participants, and is designed to evaluate the drug in patients with HIV-1 Infection who are virologically suppressed on antiretroviral therapy.
ART is being evaluated in one Phase 3 clinical trial, identified as NCT05631093. This trial, titled 'A Switch to Doravirine/Islatravir (DOR/ISL) in Participants With Human Immunodeficiency Virus Type 1 (HIV-1) Who Are Virologically Suppressed on Antiretroviral Therapy (ART)', is active but not recruiting, with an enrollment of 553 participants across multiple countries.
ART is being studied as part of a combination therapy with doravirine and islatravir, as indicated in the clinical trial title. The trial evaluates a switch to Doravirine/Islatravir (DOR/ISL) in participants with HIV-1 Infection. ART itself refers to antiretroviral therapy, which is the standard treatment for HIV-1.