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Antiretroviral Agent

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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 8 (baseline) and week 97
Awards & highlights

Study Summary

This trial is testing a new combination drug to see if it is better than current treatments for people with HIV who have tried many other treatments.

Eligible Conditions
  • HIV

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 8 (baseline) and week 97
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 8 (baseline) and week 97 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage of Participants Receiving Doravirine/Islatravir (DOR/ISL) With ≥0.5 log10 Change From Day 1 Baseline to Day 8 in Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Compared to Placebo Treatment
Percentage of Participants With ≥1 AEs Through Week 49
Percentage of Participants With ≥1 Adverse Events (AEs) Through Week 25
+2 more
Secondary outcome measures
Change From Baseline Day 1 to Week 25 in Cluster of Differentiation 4+ (CD4+) T-cell Counts From the Pooled Treatment Group
Change From Baseline Day 1 to Week 49 in CD4+ T-cell Counts From the Pooled Treatment Group
Change From Baseline Day 1 to Week 97 in CD4+ T-cell Counts From the Pooled Treatment Group
+53 more

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%
Intermittent claudication
7%
Oropharyngeal pain
7%
Alanine aminotransferase increased
7%
Humerus fracture
7%
Arthralgia
7%
Hypertension
7%
C-reactive protein increased
7%
Motor dysfunction
7%
Haematuria
7%
Proteinuria
7%
Sleep terror
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

4Treatment groups
Experimental Treatment
Placebo Group
Group I: ISL + ARTExperimental Treatment2 Interventions
HTE participants with HIV-1 infection take ISL 0.75 mg once daily (QD) in combination with failing ART from Day 1 to Day 7; followed by open-label 100 mg DOR/0.75 mg ISL fixed dose combination (FDC) QD + OBT from Day 8 to Week 97.
Group II: DOR/ISL + ARTExperimental Treatment1 Intervention
HTE participants with HIV-1 infection take 100 mg DOR/0.75 mg ISL FDC QD in combination with failing ART from Day 1 to Day 7; followed by open-label 100 mg DOR/0.75 mg ISL FDC QD + OBT from Day 8 to Week 97.
Group III: DOR + ARTExperimental Treatment2 Interventions
HTE participants with HIV-1 infection take DOR 100 mg QD in combination with failing ART from Day 1 to Day 7; followed by open-label 100 mg DOR/0.75 mg ISL FDC QD + OBT from Day 8 to Week 97.
Group IV: Placebo + ARTPlacebo Group3 Interventions
HTE participants with HIV-1 infection take placebo QD in combination with failing ART from Day 1 to Day 7; followed by open-label 100 mg DOR/0.75 mg ISL FDC QD + OBT from Day 8 to Week 97.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ISL
2021
Completed Phase 3
~530
DOR
2020
Completed Phase 3
~40
DOR/ISL
2020
Completed Phase 3
~80

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme Corp.Lead Sponsor
2,286 Previous Clinical Trials
4,582,291 Total Patients Enrolled
Merck Sharp & Dohme LLCLead Sponsor
3,898 Previous Clinical Trials
5,062,607 Total Patients Enrolled
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,782 Previous Clinical Trials
8,065,979 Total Patients Enrolled

Media Library

Doravirine (Antiretroviral Agent) Clinical Trial Eligibility Overview. Trial Name: NCT04233216 — Phase 3
HIV Research Study Groups: DOR/ISL + ART, ISL + ART, DOR + ART, Placebo + ART
HIV Clinical Trial 2023: Doravirine Highlights & Side Effects. Trial Name: NCT04233216 — Phase 3
Doravirine (Antiretroviral Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04233216 — Phase 3

Frequently Asked Questions

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

What is the latest update on DOR/ISL's FDA status?

"The safety of DOR/ISL is estimated to be a 3. This rating comes from the fact that this is a Phase 3 trial, which means there is evidence supporting its efficacy as well as multiple rounds of data affirming its safety."

Answered by AI

What are we hoping to learn from this clinical trial?

"The sponsor of this study, Merck Sharp & Dohme Corp., reports that the primary objective is to measure the percentage of participants withdrawing from study treatment due to AE(s). This will be done by comparing Day 1 (baseline) data with Day 8 data. Additionally, the trial will secondary outcomes like Prevalence of viral drug resistance to DOR and Percentage of participants discontinuing from study therapy due to AE(s)."

Answered by AI

For what medical conditions is DOR/ISL usually prescribed?

"DOR/ISL is most commonly used when the patient does not have doravirine resistance-associated mutations. It can also be taken to treat conditions including treatment failure, antiretroviral treatment naive, and antiretroviral therapy."

Answered by AI

How many people are currently enrolled in this clinical trial?

"This research is no longer actively recruiting patients. The trial was originally posted on March 18th, 2020 and last edited on August 24th, 2022. 892 other trials for human immunodeficiency virus type 1 (hiv-1) infection are currently active and looking for participants while 22 DOR/ISL studies are still enrolling individuals."

Answered by AI

Have similar medical experiments been conducted previously?

"DOR/ISL has been under investigation since 2014. Merck Sharp & Dohme LLC conducted the very first clinical trial in 2014, which then led to Phase 3 drug approval after 769 people had participated. As of now, there are 22 live studies being conducted in 146 cities and 27 countries."

Answered by AI

How many different hospitals are participating in this research project?

"Currently, this trial is taking place at Howard Brown Health Center ( Site 4006) in Chicago, Illinois, Saint Hope Foundation, Inc. ( Site 4034) in Bellaire, Texas and Icahn School of Medicine at Mount Sinai ( Site 4000) in New york, New York with an additional 20 sites across the country."

Answered by AI

Are you looking for more participants in this research?

"As of right now, this particular clinical trial is not recruiting patients. However, that could change in the future as the study was last edited on 8/24/2022. If you are looking for other trials to participate in, there are currently 892 different clinical trials actively recruiting patients with human immunodeficiency virus type 1 (hiv-1) infection and 22 DOR/ISL trials enrolling participants."

Answered by AI

Are there any precedent studies to compare this research too?

"Presently, there are 22 ongoing clinical trials researching DOR/ISL with 10 in Phase 3. The majority of the studies for DOR/ISL originate from Cape Town, Western Cape; though, 350 locations worldwide are conducting research on DOR/ISL."

Answered by AI

Who else is applying?

What state do they live in?
Wisconsin
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
Doravirine/Islatravir (DOR/ISL) in Heavily Treatment-Experienced (HTE) Participants for Human Immunodeficiency Virus Type 1 (HIV-1) Infection (MK-8591A-019)
2020. "Doravirine/Islatravir (DOR/ISL) in Heavily Treatment-Experienced (HTE) Participants for Human Immunodeficiency Virus Type 1 (HIV-1) Infection (MK-8591A-019)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04233216.
~7 spots leftby May 2025
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