Clinical Trials in Taiwan / NCT05766501
Active, not recruiting
Phase 3
A Study of Doravirine/Islatravir (DOR/ISL, MK-8591A) for the Treatment of Human Immunodeficiency Virus 1 (HIV-1) Infection in Participants Who Previously Received DOR/ISL (MK-8591A-054)
NCT05766501 · tracked via the Priya Life Science Taiwan tracker
Condition(s) studied
HIV Infection
Investigational drug(s) / intervention(s)
DOR/ISL: FDC tablet of 100 mg doravirine (DOR)/0.25 mg islatravir (ISL) taken once daily
Study summary
The purpose of this study is to evaluate the safety and tolerability of DOR/ISL in adult participants with HIV-1 who had been previously treated with DOR/ISL in earlier clinical studies. There are no formal hypotheses to be tested in this study.
Eligibility
Inclusion Criteria:
* Is currently receiving doravirine/islatravir (DOR/ISL) adult fixed dose combination (FDC) tablet in Merck Sharp \& Dohme (MSD)-sponsored clinical studies (MK-8591A-018, -020, and -033 \[except for heavily treatment-experienced (HTE) participants\]).
Exclusion Criteria:
* Has confirmed HIV-1 RNA ≥200 copies/mL in MSD DOR/ISL (100 mg/0.75 mg) MK-8591A-018 /-020, or at screening for participants entering from DOR/ISL (100 mg/0.75 mg) MK-8591A-033.
* Has confirmatory laboratory findings for cluster of differentiation 4+ (CD4+) T-cell counts or lymphocyte counts in the prior DOR/ISL study that meet criteria for discontinuation of DOR/ISL.
* Is a HTE participant receiving treatment in MK-8591A-019 or -033.
Primary outcome measure(s)
- Percentage of Participants with One or More Adverse Event (AE) — Up to 96 Weeks
An AE is 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. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The percentage of participants who experience an AE through Week 96 will be presented. - Percentage of participants who Discontinue Study Intervention Due to an AE — Up to 96 Weeks
An AE is 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. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The percentage of participants who discontinue study intervention due to an AE through Week 96 will be presented.
Trial sites (95)
| Facility | City | Region | Status |
|---|---|---|---|
| University of Alabama at Birmingham-UAB 1917 Research Clinic ( Site 3104) | Birmingham | Alabama | |
| Pueblo Family Physicians ( Site 3102) | Phoenix | Arizona | |
| Pacific Oaks Medical Group ( Site 3123) | Beverly Hills | California | |
| Kaiser Permanente ( Site 3124) | Los Angeles | California | |
| Ruane Clinical Research Group, Inc ( Site 3126) | Los Angeles | California | |
| Mills Clinical Research ( Site 3114) | Los Angeles | California | |
| University of California Davis Health-Internal Medicine: Infectious Diseases ( Site 3137) | Sacramento | California | |
| Georgetown University Medical Center ( Site 3130) | Washington D.C. | District of Columbia | |
| Therafirst Medical Center ( Site 3110) | Fort Lauderdale | Florida | |
| Midway Immunology and Research Center ( Site 3117) | Ft. Pierce | Florida | |
| AHF The Kinder Medical Group ( Site 3108) | Miami | Florida | |
| Floridian Clinical Research, LLC ( Site 3133) | Miami Lakes | Florida | |
| Orlando Immunology Center ( Site 3106) | Orlando | Florida | |
| Bliss Healthcare Services ( Site 3115) | Orlando | Florida | |
| CAN Community Health - Sarasota ( Site 3118) | Sarasota | Florida | |
| Triple O Research Institute, P.A ( Site 3116) | West Palm Beach | Florida | |
| Augusta University-Infectious Diseases ( Site 3135) | Augusta | Georgia | |
| Infectious Disease Specialists of Atlanta ( Site 3128) | Decatur | Georgia | |
| Mercer university, Department of internal medicine-Clinical Research ( Site 3129) | Macon | Georgia | |
| Chatham County Health Department - Chatham CARE Center-Infectious Disease ( Site 3105) | Savannah | Georgia | |
| KC CARE Health Center ( Site 3103) | Kansas City | Missouri | |
| ID Care ( Site 3131) | Hillsborough | New Jersey | |
| Icahn School of Medicine at Mount Sinai-Clinical and Translational Research Center ( Site 3134) | New York | New York | |
| Penn Medicine: University of Pennsylvania Health System-Perelman Center for Advanced Medicine ( Site | Philadelphia | Pennsylvania | |
| St Hope Foundation ( Site 3121) | Bellaire | Texas | |
| North Texas Infectious Diseases Consultants, P.A ( Site 3100) | Dallas | Texas | |
| Texas Centers for Infectious Disease Associates ( Site 3111) | Fort Worth | Texas | |
| The Crofoot Research Center ( Site 3101) | Houston | Texas | |
| DCOL Center for Clinical Research ( Site 3119) | Longview | Texas | |
| Private Practice - Dr. Peter Shalit ( Site 3120) | Seattle | Washington | |
| Multicare Institute for Research and Innovation ( Site 3127) | Spokane | Washington | |
| Instituto Oulton ( Site 1004) | Córdoba | Córdoba Province | |
| Instituto CAICI SRL ( Site 1003) | Rosario | Santa Fe Province | |
| Helios Salud ( Site 1002) | Buenos Aires | Argentina | |
| Fundación Huésped ( Site 1001) | Buenos Aires | Argentina | |
| Fundación IDEAA ( Site 1005) | Buenos Aires | Argentina | |
| Holdsworth House Medical Practice ( Site 1100) | Darlinghurst | New South Wales | |
| St Vincent's Hospital-IBAC ( Site 1103) | Sydney | New South Wales | |
| Holdsworth House Medical Practice - Brisbane ( Site 1101) | Brisbane | Queensland | |
| Prahran Market Clinic ( Site 1102) | Melbourne | Victoria |
+ 55 more sites — see the full list on the official registry below.
More Merck Sharp & Dohme LLC trials in Taiwan
Efficacy and Safety of Pembrolizumab (MK-3475) in Combination With Bacillus Calmette-Guerin (BCG) in High-Risk Non-Muscle Invasive Bladder Cancer (HR NMIBC) (MK-3475-676/KEYNOTE-676)
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 NCT05766501 on ClinicalTrials.gov ↗ ← All trials in Taiwan