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Antiretroviral

DOR/ISL for HIV

Phase 3
Waitlist Available
Research Sponsored by Merck Sharp & Dohme Corp.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to week 198
Awards & highlights

Study Summary

This trial will look at the safety and tolerability of a new two-drug combination of HIV medications in adults and children who have already taken them individually.

Who is the study for?
This trial is for individuals over 35 kg with HIV-1 who are benefiting from the DOR/ISL tablet in a previous MSD study. Participants must not be pregnant or breastfeeding unless local regulations allow and they agree to contraception if of childbearing potential.Check my eligibility
What is being tested?
The trial studies MK-8591A, a combination of doravirine (100mg) and islatravir (0.75mg), assessing its safety and tolerability in those previously treated with these drugs for HIV-1.See study design
What are the potential side effects?
While specific side effects aren't listed here, common ones associated with HIV treatments include nausea, headache, fatigue, diarrhea, and possible liver issues. Individual experiences may vary.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to week 198
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to week 198 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Participants who discontinued due to an adverse event (AE)
Participants with serious adverse events (SAEs)

Side effects data

From 2023 Phase 3 trial • 35 Patients • NCT04233216
29%
Diarrhoea
21%
Lymphocyte count decreased
21%
COVID-19
21%
Creatinine renal clearance decreased
14%
Headache
14%
Fatigue
14%
Nausea
14%
Accidental overdose
14%
Rash
7%
Oropharyngeal pain
7%
Alanine aminotransferase increased
7%
Humerus fracture
7%
C-reactive protein increased
7%
Arthralgia
7%
Motor dysfunction
7%
Intermittent claudication
7%
Hypertension
7%
Proteinuria
7%
Sleep terror
7%
Haematuria
7%
Postoperative wound infection
7%
Urinary tract infection
7%
Pancytopenia
7%
Memory impairment
7%
Dry eye
7%
Intestinal transit time increased
7%
Eye irritation
7%
Skin candida
7%
Upper respiratory tract infection
7%
Obesity
7%
Anaemia
7%
Chest pain
7%
Exposure to communicable disease
7%
Abdominal pain
7%
Mitral valve incompetence
7%
Pyrexia
7%
Blood creatine phosphokinase increased
7%
Amoebiasis
7%
Blood calcium increased
7%
Anaemia postoperative
7%
Blood cholesterol increased
7%
Respiratory tract infection viral
7%
Device dislocation
7%
Blood glucose increased
7%
Myelopathy
7%
Cough
7%
Night sweats
7%
Peripheral arterial occlusive disease
100%
80%
60%
40%
20%
0%
Study treatment Arm
DOR+ART
DOR/ISL+ART
Placebo+ART
ISL+ART

Trial Design

1Treatment groups
Experimental Treatment
Group I: MK-8591AExperimental Treatment1 Intervention
Fixed dose combination (FDC) tablet of 100 mg doravirine, 0.75 mg islatravir taken orally, once daily for up to 192 weeks.

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme Corp.Lead Sponsor
2,286 Previous Clinical Trials
4,579,828 Total Patients Enrolled
Merck Sharp & Dohme LLCLead Sponsor
3,886 Previous Clinical Trials
5,052,553 Total Patients Enrolled
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,777 Previous Clinical Trials
8,061,486 Total Patients Enrolled

Media Library

MK-8591A (Antiretroviral) Clinical Trial Eligibility Overview. Trial Name: NCT04776252 — Phase 3
HIV Research Study Groups: MK-8591A
HIV Clinical Trial 2023: MK-8591A Highlights & Side Effects. Trial Name: NCT04776252 — Phase 3
MK-8591A (Antiretroviral) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04776252 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals are taking part in this research project?

"Yes, the data on clinicaltrials.gov point out that this trial is presently recruiting candidates. The study was first posted on 9/15/2021 and was last edited on 11/17/2022. The trial is recruiting for 2000 patients at 22 locations."

Answered by AI

Are there any risks that come with taking MK-8591A?

"MK-8591A's safety is estimated to be a 3. This rating comes from the fact that this is a Phase 3 trial, meaning there is efficacy data as well as multiple rounds of safety data supporting this estimate."

Answered by AI

Is this a full clinical trial or are there still open positions for patients?

"As noted on clinicaltrials.gov, this trial is actively seeking participants. The original posting was on 9/15/2021, and the most recent update was on 11/17/2022."

Answered by AI

In how many different hospitals is this experiment being conducted today?

"Currently, there are 22 sites participating in this trial. Examples of locations include Hamilton General Hospital-Special Immunology Services Clinic ( Site 0109) in Bellaire, St Hope Foundation ( Site 0041) in Orlando, and Bliss Healthcare Services-Research ( Site 0030) in Vancouver."

Answered by AI

Who else is applying?

What state do they live in?
Texas
How old are they?
18 - 65
What site did they apply to?
North Texas Infectious Diseases Consultants, P.A-Research ( Site 0004)
Hamilton General Hospital-Special Immunology Services Clinic ( Site 0109)
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
Recent research and studies
clinicaltrials.govStudy
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)
2021. "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)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04776252.
All > Rsv > Hiv
~1123 spots leftby Oct 2027
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