NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
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
Health condition(s) or Problem(s) studiedHIV-1 Infection
Date of first enrollment12/01/2022
Target sample size32
Countries of recruitmentUnited 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 typeInterventional
Intervention(s)Doravirine/Islatravir(100 mg/0.75 mg) FDC tablet taken once daily by mouth for 48 weeks

Outcome(s)

Primary OutcomePercentage of participants experiencing SAEs or discontinuing study intervention due to an AE.
Secondary Outcome

Key inclusion & exclusion criteria

Age minimumNot applicable
Age maximumNot applicable
GenderBoth
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 criteriaIs taking or is anticipated to require any prohibited therapies.

Related Information

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
E-mail 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
E-mail msdjrct@merck.com
Affiliation MSD K.K.