JRCT ID: jRCT2031210528
Registered date:26/12/2021
Open-label, Follow-up of DOR/ISL for HIV-1 Infection
Basic Information
Recruitment status | Not Recruiting |
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Health condition(s) or Problem(s) studied | HIV-1 Infection |
Date of first enrollment | 12/01/2022 |
Target sample size | 32 |
Countries of recruitment | United States of America,Japan,Argentina,Japan,Australia,Japan,Canada,Japan,Chile,Japan,Colombia,Japan,Finland,Japan,France,Japan,Germany,Japan,Israel,Japan,Italy,Japan,Mexico,Japan,New Zealand,Japan,Peru,Japan,Poland,Japan,Portugal,Japan,Puerto Rico,Japan,Russia,Japan,South Africa,Japan,South Korea,Japan,Spain,Japan,Switzerland,Japan,Taiwan,Japan,Thailand,Japan,Ukraine,Japan,United Kingdom,Japan |
Study type | Interventional |
Intervention(s) | Doravirine/Islatravir(100 mg/0.75 mg) FDC tablet taken once daily by mouth for 48 weeks |
Outcome(s)
Primary Outcome | Percentage of participants experiencing SAEs or discontinuing study intervention due to an AE. |
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Secondary Outcome |
Key inclusion & exclusion criteria
Age minimum | Not applicable |
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Age maximum | Not applicable |
Gender | Both |
Include criteria | - Is currently receiving DOR/ISL adult FDC tablet in a Merck-sponsored clinical study and has completed the last treatment visit. - Is considered by the investigator to have derived clinical benefit from receiving DOR/ISL and for whom further treatment with DOR/ISL is considered clinically appropriate. - Is male or female and >=35 kg at the time of signing the informed consent/assent. - Female is not pregnant or breastfeeding, and at least one of the following conditions applies: Is not a woman of childbearing potential (WOCBP); or is a non-pregnant WOCBP who agrees to the following during the intervention period and for at least 6 weeks after the last dose of study intervention: Not be sexually active, or if sexually active, to use an acceptable method of contraception |
Exclude criteria | Is taking or is anticipated to require any prohibited therapies. |
Related Information
Primary Sponsor | Tanaka Yoshiyuki |
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Secondary Sponsor | |
Source(s) of Monetary Support | |
Secondary ID(s) | NCT04776252 |
Contact
Public contact | |
Name | inquiry mailbox MSDJRCT |
Address | KITANOMARU SQUARE,1-13-12,Kudan-kita,Chiyoda-ku,Tokyo 102-8667,Japan Tokyo Japan 102-8667 |
Telephone | +81-3-6272-1957 |
msdjrct@merck.com | |
Affiliation | MSD K.K. |
Scientific contact | |
Name | Yoshiyuki Tanaka |
Address | KITANOMARU SQUARE,1-13-12,Kudan-kita,Chiyoda-ku,Tokyo 102-8667,Japan Tokyo Japan 102-8667 |
Telephone | +81-3-6272-1957 |
msdjrct@merck.com | |
Affiliation | MSD K.K. |