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Chemxpert database is a techno-commercial information platform developed and operated by Lifescience Intellipedia Pvt. Ltd. Our data provides valuable insights regarding sourcing, marketing, development, and regulatory functions for the entire Lifescience industry. The different industries covered by our data encompass APIs, FDFs, pharma intermediates, paints, dyes, polymers, biotechnology, biochemical, food additives, nutraceuticals, etc.

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21 Sep 2022
Admin
News Article

Merck to begin new phase 3 clinical programme with lower dose of daily oral islatravir in combo with doravirine to treat HIV-1 infection

Merck, known as MSD outside of the United States and Canada, announced that the company will initiate a new phase 3 clinical programme with once-daily islatravir for the treatment of people with HIV-1 infection. These new phase 3 studies will evaluate a once-daily oral combination of doravirine 100 mg and a lower dose of islatravir (DOR/ISL). One study will evaluate DOR/ISL in previously untreated adults with HIV-1 infection and two studies will evaluate DOR/ISL as a switch in antiretroviral therapy (ART) in adults with HIV-1 infection who are virologically suppressed. Certain study participants currently enrolled in once-daily treatment studies with DOR 100 mg/ISL 0.75 mg will have the option of transitioning to a new study with the lower islatravir dose. The US Food and Drug Administration (FDA) has reviewed and agreed with this plan. The investigational new drug application (IND) for the once-daily oral DOR/ISL treatment programme remains under a partial clinical hold for any studies that would use doses higher than the dose to be studied in the new phase 3 programme. Refer here for more information on the islatravir clinical hold. The phase 2 clinical trial (NCT05052996) evaluating an investigational oral once-weekly combination treatment regimen of islatravir and Gilead

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