臨床研究等提出・公開システム

A Phase 3, Randomized, Active-Controlled, Double-Blind Clinical Study to Evaluate the Antiretroviral Activity, Safety, and Tolerability of Doravirine/Islatravir (DOR/ISL 100 mg/0.25 mg) Once-Daily in HIV-1 Infected Treatment-Naive Participants

DOR/ISL 100 mg/0.25 mg QD in HIV-1 antiretroviral treatment naive

Iwamoto Taro

MSD K.K.

KITANOMARU SQUARE,1-13-12,Kudan-kita,Chiyoda-ku,Tokyo 102-8667,Japan

msdjrct@merck.com

MSDJRCT inquiry mailbox

MSD K.K.

KITANOMARU SQUARE,1-13-12,Kudan-kita,Chiyoda-ku,Tokyo 102-8667,Japan

+81-3-6272-1957

msdjrct@merck.com

Not Recruiting

Mar. 30, 2023

Interventional

randomized controlled trial

double blind

active control

parallel assignment

treatment purpose

- Is HIV-1 positive with plasma HIV-1 RNA >=500 copies/mL at screening
- Is naive to antiretroviral therapy (ART) defined as having received no prior therapy with any antiretroviral agent following a diagnosis of HIV-1 infection
- If female, is not a participant of childbearing potential (POCBP); or if a POCBP, is not pregnant or breastfeeding, and is willing to use an acceptable contraceptive method or abstain from heterosexual intercourse for study duration

- Has HIV-2 infection
- Has hypersensitivity or other contraindication to any of the components of the study interventions as determined by the investigator
- Has a diagnosis of an active AIDS-defining opportunistic infection within 30 days prior to screening
- Has active hepatitis B virus (HBV) infection (defined as hepatitis B surface antigen [HBsAg]-positive or HBV deoxyribonucleic acid [DNA]-positive).
- Has chronic hepatitis C virus (HCV) infection (detectable HCV ribonucleic acid [RNA]) and lab values are consistent with cirrhosis
- Has a history of malignancy <=5 years prior to providing documented informed consent except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or cutaneous Kaposi's sarcoma
- Has a history or current evidence of any condition (including active tuberculosis infection), therapy, laboratory abnormality, or other circumstance (including drug or alcohol use or dependence) that might, in the opinion of the investigator, confound the results of the study or interfere with the participant's participation for the full duration of the study, such that it is not in the best interest of the participant to participate

Both

HIV-1 Infection

Experimental: DOR/ISL (100 mg/0.25 mg) and placebo to BIC/FTC/TAF once daily (qd) for 144 weeks

Active comparator: BIC/FTC/TAF (50 mg/200 mg/25 mg) and placebo to DOR/ISL qd for 144 weeks

Abbreviations: BIC=bictegravir, DOR=doravirine, FTC=emtricitabine, ISL=islatravir, TAF=tenofovir alafenamide

1. Percentage of participants with HIV-1 RNA <50 copies/mL at Week 48
2. Percentage of participants experiencing >=1 AEs through Week 48
3. Percentage of participants discontinuing from study treatment due to an AE through Week 48

1. Percentage of participants with HIV-1 RNA <50 copies/mL at Week 96
2. Percentage of participants with HIV-1 RNA <50 copies/mL at Week 144
3. Percentage of participants with HIV-1 RNA <200 copies/mL at Week 48
4. Percentage of participants with HIV-1 RNA <200 copies/mL at Week 96
5. Percentage of participants with HIV-1 RNA <200 copies/mL at Week 144
6. Change from baseline in cluster of differentiation 4+ (CD4+) T-cells at Week 48
7. Change from baseline in CD4+ T-cells at Week 96
8. Change from baseline in CD4+ T-cells at Week 144
9. Incidence of viral drug resistance
10. Change from baseline in body weight at Week 48
11. Change from baseline in body weight at Week 96
12. Change from baseline in body weight at Week 144
13. Percentage of participants experiencing >=1 AE through Week 144
14. Percentage of participants discontinuing from study treatment due to an AE through Week 144

+81-3-3342-6111

Mar. 14, 2023

Yes

http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

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