Clinical Trials in Japan / NCT05630755
Active, not recruiting
Phase 3
A Switch to Doravirine/Islatravir (DOR/ISL) in Participants With Human Immunodeficiency Virus Type 1 (HIV-1) Who Are Virologically Suppressed on Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF) (MK-8591A-052)
NCT05630755 · tracked via the Priya Life Science Japan tracker
Condition(s) studied
HIV-1 Infection
Investigational drug(s) / intervention(s)
DOR/ISL: DOR/ISL 100 mg/0.25 mg oral tablets once daily
BIC/FTC/TAF: BIC/FTC/TAF 50 mg/200 mg/25 mg oral tablets once daily
Placebo to BIC/FTC/TAF: 0 mg oral tablets once daily
Placebo to DOR/ISL: 0 mg oral tablets once daily
Study summary
The primary objectives of this study are to evaluate the antiretroviral activity of a switch to Doravirine/Islatravir (DOR/ISL) compared with continued Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF) at Week 48; and to evaluate the safety and tolerability of a switch to DOR/ISL compared with continued BIC/FTC/TAF, through Week 48. The primary hypotheses are that (1) DOR/ISL is non-inferior to continued BIC/FTC/TAF, as assessed by the percentage of participants with HIV-1 ribonucleic acid (RNA) ≥50 copies/mL at Week 48, with a margin of 4 percentage points used to define non-inferiority; and (2) DOR/ISL is superior to BIC/FTC/TAF, as assessed by the percentage of participants with HIV-1 RNA ≥50 copies/mL at Week 48.
Eligibility
The key inclusion and exclusion criteria include but are not limited to the following:
Inclusion Criteria:
* Is HIV-1 positive with plasma HIV-1 RNA \<50 copies/mL
* Has been receiving BIC/FTC/TAF therapy with documented viral suppression (HIV-1 RNA \<50 copies/mL) for ≥3 consecutive months prior to providing documented informed consent and has no history of prior virologic treatment failure on any past or current regimen
* Female is not a participant of childbearing potential (POCBP); or if a participant of childbearing potential, not pregnant or breastfeeding, and is willing to use an acceptable contraceptive method or abstain from heterosexual intercourse for study duration
Exclusion Criteria:
* Has HIV-2 infection
* Has a diagnosis of an active acquired immunodeficiency syndrome (AIDS)-defining opportunistic infection within 30 days prior to screening
* Has active hepatitis B virus (HBV) infection
* Has chronic hepatitis C virus (HCV) infection with laboratory values 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
* Is taking or is anticipated to require systemic immunosuppressive therapy, immune modulators, or strong and moderate cytochrome P450 3A (CYP3A) inducers
* Has a documented or known virologic resistance to DOR
* Has taken long-acting HIV therapy at any time (e.g., cabotegravir, lenacapavir)
* Is currently participating in or has participated in a clinical study and received (or is receiving) an investigational compound or device from 45 days prior to Day 1 through the study treatment period except those currently enrolled in the comparator arm of an ongoing DOR/ISL study
Primary outcome measure(s)
- Percentage of Participants With Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) ≥50 Copies/mL at Week 48 — Week 48
HIV-1 RNA levels in blood samples taken at each visit were measured 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. - Percentage of Participants Who Experience Adverse Events (AEs) Through Week 48 — Up to Week 48
An AE was 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 is reported. - Percentage of Participants Who Discontinue Study Intervention Due to AEs Through Week 48 — Up to Week 48
An AE was 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 discontinued study intervention due to an AE is reported.
Trial sites (49)
| Facility | City | Region | Status |
|---|---|---|---|
| Pueblo Family Physicians ( Site 1425) | Phoenix | Arizona | |
| Pacific Oaks Medical Group ( Site 1400) | Beverly Hills | California | |
| Ruane Clinical Research Group, Inc ( Site 1414) | Los Angeles | California | |
| Mills Clinical Research ( Site 1433) | Los Angeles | California | |
| Whitman-Walker Institute ( Site 1431) | Washington D.C. | District of Columbia | |
| Therafirst Medical Center ( Site 1402) | Fort Lauderdale | Florida | |
| Midway Immunology and Research Center ( Site 1401) | Ft. Pierce | Florida | |
| AHF The Kinder Medical Group ( Site 1426) | Miami | Florida | |
| Orlando Immunology Center ( Site 1407) | Orlando | Florida | |
| Triple O Research Institute, P.A ( Site 1417) | West Palm Beach | Florida | |
| Infectious Disease Specialists of Atlanta ( Site 1403) | Decatur | Georgia | |
| Mercer University, Department of Internal Medicine ( Site 1411) | Macon | Georgia | |
| AccessHealth MA ( Site 1419) | Boston | Massachusetts | |
| Be Well Medical Center ( Site 1408) | Berkley | Michigan | |
| KC CARE Health Center-Clinical Trials ( Site 1422) | Kansas City | Missouri | |
| Las Vegas Research Center ( Site 1436) | Las Vegas | Nevada | |
| Regional Center for Infectious Disease Research ( Site 1435) | Greensboro | North Carolina | |
| Central Texas Clinical Research ( Site 1413) | Austin | Texas | |
| St Hope Foundation ( Site 1410) | Bellaire | Texas | |
| Prism Health North Texas, Oak Cliff Health Center ( Site 1409) | Dallas | Texas | |
| North Texas Infectious Diseases Consultants, P.A ( Site 1404) | Dallas | Texas | |
| Texas Centers for Infectious Disease Associates ( Site 1406) | Fort Worth | Texas | |
| The Crofoot Research Center ( Site 1424) | Houston | Texas | |
| DCOL Center for Clinical Research ( Site 1415) | Longview | Texas | |
| Holdsworth House Medical Practice ( Site 6200) | Darlinghurst | New South Wales | |
| St Vincent's Hospital-IBAC ( Site 6203) | Sydney | New South Wales | |
| Holdsworth House Medical Practice - Brisbane ( Site 6201) | Brisbane | Queensland | |
| Royal Brisbane and Women's Hospital-Infectious Diseases Research ( Site 6204) | Brisbane | Queensland | |
| Prahran Market Clinic ( Site 6202) | Melbourne | Victoria | |
| Hospital hernan henriquez aravena de temuco-Unidad de Investigación Clínica ( Site 2205) | Temuco | Araucania | |
| Clinica Universidad Catolica del Maule ( Site 2204) | Talca | Maule Region | |
| Clínica Universidad de Los Andes ( Site 2206) | Santiago | Region M. de Santiago | |
| Universidad de Chile - Hospital Clínico Universidad de Chile-Inmunologia Alergia y VIH ( Site 2200) | Santiago | Region M. de Santiago | |
| Rambam Health Care Campus-Institute of Allergy, Clinical Immunology, ( Site 4801) | Haifa | Israel | |
| Hadassah Medical Center-Infecious Disease ( Site 4802) | Jerusalem | Israel | |
| Sheba Medical Center-HIV unit ( Site 4803) | Ramat Gan | Israel | |
| Sourasky Medical Center ( Site 4804) | Tel Aviv | Israel | |
| National Hospital Organization Nagoya Medical Center ( Site 6603) | Nagoya | Aichi-ken | |
| Center Hospital of the National Center for Global Health and Medicine ( Site 6601) | Shinjyuku-ku | Tokyo | |
| National Hospital Organization - Osaka National Hospital - Institute For Clinical Research ( Site 66 | Osaka | Japan |
+ 9 more sites — see the full list on the official registry below.
More Merck Sharp & Dohme LLC trials in Japan
A Study to Evaluate Sacituzumab Tirumotecan (MK-2870) in Advanced/Metastatic Gastroesophageal Adenocarcinoma (MK-2870-015)
Active, not recruiting
Other trials for the same condition
Open-label, Follow-up of Doravirine/Islatravir (DOR/ISL 100 mg/0.75mg) for Participants With Human Immunodeficiency Virus-1 (HIV-1) Infection (MK-8591A-033)
Active, not recruiting
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) (MK-8591A-051)
Active, not recruiting
DOR/ISL in HIV-1 Antiretroviral Treatment-naïve Participants (MK-8591A-053)
Active, not recruiting
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05630755 on ClinicalTrials.gov ↗ ← All trials in Japan