DOR/ISL for Human Immunodeficiency Virus Type 1 (HIV-1) Infection

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Human Immunodeficiency Virus Type 1 (HIV-1) Infection+1 More
DOR/ISL - Drug
Eligibility
Any Age
All Sexes
What conditions do you have?
Select

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
  • Human Immunodeficiency Virus Type 1 (HIV-1) Infection

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Other trials for Human Immunodeficiency Virus Type 1 (HIV-1) Infection

1
1

Study Objectives

2 Primary · 23 Secondary · Reporting Duration: Day 8 (baseline) and Week 97

Day 8
Mean change from baseline in HIV-1 RNA following treatment with DOR/ISL (given with ART) compared to DOR or ISL treatment
Mean change from baseline in HIV-1 RNA following treatment with DOR/ISL (given with ART), DOR, or ISL compared to placebo treatment
Percentage of participants receiving DOR or ISL (given with antiretoviral therapy [ART]) with ≥0.5 log10 decrease in HIV-1 RNA compared to placebo treatment
Percentage of participants receiving DOR/ISL (given with ART) with ≥0.5 log10 decrease from baseline in HIV-1 RNA compared to DOR or ISL treatment
Percentage of participants receiving DOR/ISL (given with ART) with ≥1.0 log10 decrease from baseline in HIV-1 RNA compared to DOR or ISL treatment
Percentage of participants receiving DOR/ISL (given with ART), DOR, or ISL with ≥1.0 log10 decrease from baseline in HIV-1 RNA compared to placebo treatment
Percentage of participants receiving doravirine/islatravir (DOR/ISL) with ≥0.5 log10 decrease from baseline in human immunodificiency virus type 1 (HIV-1) ribonucleic acid (RNA) compared to placebo treatment
Week 25
Change from baseline in cluster of differentiation 4+ (CD4+) T-cell counts
Role of baseline antiviral resistance on viral resistance-associated substitutions (RASs)
Week 97
Percentage of participants receiving DOR/ISL (given with ART) + OBT with HIV-1 RNA <200 copies mL
Percentage of participants receiving DOR/ISL (given with ART) + OBT with HIV-1 RNA <40 copies mL
Percentage of participants receiving DOR/ISL (given with ART) + OBT with HIV-1 RNA <50 copies mL
Percentage of participants receiving DOR/ISL (given with ART) + OBT with ≥0.5 log10 decrease from baseline in HIV-1 RNA compared to DOR or ISL treatment
Percentage of participants receiving DOR/ISL (given with ART) + OBT with ≥1.0 log10 decrease from baseline in HIV-1 RNA compared to DOR or ISL treatment
Role of baseline antiviral resistance on viral RASs
Week 97
Change from baseline in CD4+ T-cell counts
Mean change from baseline in HIV-1 RNA following treatment with DOR/ISL (given with ART) + OBT
Role of baseline antiviral resistance on HIV-1 RNA
Up to 49 weeks
Percentage of participants withdrawing from study treatment due to AE(s)
Up to 97 weeks
Percentage of participants discontinuing from study therapy due to AE(s)
Percentage of participants with ≥1 adverse events (AEs)
Week 25
Prevalence of viral drug resistance to optimized background therapy (OBT) components
Week 49
Prevalence of viral drug resistance to DOR
Prevalence of viral drug resistance to ISL
Prevalence of viral drug resistance to OBT components

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Other trials for Human Immunodeficiency Virus Type 1 (HIV-1) Infection

2
1

Side Effects for

Islatravir 0.75mg
30%Nasopharyngitis
27%Syphilis
23%Bronchitis
20%Vitamin D deficiency
17%Diarrhoea
17%Nausea
17%Anxiety
13%Fatigue
10%Abdominal pain upper
10%Vomiting
10%COVID-19
10%Upper respiratory tract infection
10%Tonsillitis
10%Pharyngitis
10%Depression
10%Oropharyngeal pain
7%Pyrexia
7%Suicide attempt
7%Oropharyngeal gonococcal infection
7%Procedural pain
7%Lower respiratory tract infection
7%Sinus congestion
7%Abdominal distension
7%Anal chlamydia infection
7%Oral herpes
7%Conjunctivitis
7%Proctitis chlamydial
7%Proctitis gonococcal
7%Viral pharyngitis
7%Alanine aminotransferase increased
7%Urethritis
7%Weight increased
7%Arthralgia
7%Back pain
7%Anogenital warts
7%Headache
7%Osteopenia
7%Nephrolithiasis
7%Adjustment disorder with depressed mood
7%Cough
7%Rhinorrhoea
7%Respiratory disorder
7%Rash
3%Large intestine infection
3%Lymphadenopathy
3%Abdominal pain
3%Ankle fracture
3%Facial paralysis
3%Appendicitis
3%Suicidal ideation
3%Alcohol withdrawal syndrome
3%Escherichia urinary tract infection
3%Gastroenteritis
3%Asthenia
3%Influenza
3%Dizziness
3%Pain in extremity
This histogram enumerates side effects from a completed 2022 Phase 2 trial (NCT03272347) in the Islatravir 0.75mg ARM group. Side effects include: Nasopharyngitis with 30%, Syphilis with 27%, Bronchitis with 23%, Vitamin D deficiency with 20%, Diarrhoea with 17%.

Trial Design

5 Treatment Groups

Part 1, Group 2: DOR + ART
1 of 5
Part 1, Group 1: ISL + ART
1 of 5
Part 2, Group 5: Open-Label DOR/ISL + OBT
1 of 5
Part 1, Group 3: DOR/ISL + ART
1 of 5
Part 1, Group 4: Placebo + ART
1 of 5
Experimental Treatment
Non-Treatment Group

100 Total Participants · 5 Treatment Groups

Primary Treatment: DOR/ISL · Has Placebo Group · Phase 3

Part 1, Group 2: DOR + ART
Drug
Experimental Group · 1 Intervention: DOR · Intervention Types: Drug
Part 1, Group 1: ISL + ART
Drug
Experimental Group · 1 Intervention: ISL · Intervention Types: Drug
Part 2, Group 5: Open-Label DOR/ISL + OBT
Drug
Experimental Group · 1 Intervention: DOR/ISL · Intervention Types: Drug
Part 1, Group 3: DOR/ISL + ART
Drug
Experimental Group · 1 Intervention: DOR/ISL · Intervention Types: Drug
Part 1, Group 4: Placebo + ARTPlaceboComparator Group · 2 Interventions: Placebo to DOR, Placebo to ISL · Intervention Types: Drug, Drug

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: day 8 (baseline) and week 97

Who is running the clinical trial?

Merck Sharp & Dohme Corp.Lead Sponsor
2,286 Previous Clinical Trials
4,579,104 Total Patients Enrolled
23 Trials studying Human Immunodeficiency Virus Type 1 (HIV-1) Infection
18,549 Patients Enrolled for Human Immunodeficiency Virus Type 1 (HIV-1) Infection
Merck Sharp & Dohme LLCLead Sponsor
3,653 Previous Clinical Trials
4,953,507 Total Patients Enrolled
47 Trials studying Human Immunodeficiency Virus Type 1 (HIV-1) Infection
22,482 Patients Enrolled for Human Immunodeficiency Virus Type 1 (HIV-1) Infection
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,618 Previous Clinical Trials
7,936,725 Total Patients Enrolled
19 Trials studying Human Immunodeficiency Virus Type 1 (HIV-1) Infection
11,646 Patients Enrolled for Human Immunodeficiency Virus Type 1 (HIV-1) Infection

Eligibility Criteria

Age Any Age · All Participants · 6 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
The person has resistance to at least three different types of drugs, including nucleoside reverse transcriptase inhibitors (NRTIs), non-nucleoside reverse transcriptase inhibitors (NNRTIs), and either protease inhibitors (PIs) or integrase strand transfer inhibitors (InSTIs)
If female, is not pregnant, breastfeeding, or of childbearing potential; uses an acceptable method of contraception/is abstinent; or has a negative pregnancy test within 24 hours of the first dose of study medication.
HIV-1 is positive.
The person has been taking the same basic ART medication for three months or more before agreeing to participate in the study.
Weighs more than 35 kg.
The text is saying that there are only a limited number of antiretroviral drugs left that can be used in a combination to form a viable regimen

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 22nd, 2021

Last Reviewed: October 27th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

Who else is applying?

What state do they live in?
Wisconsin100.0%
How old are they?
18 - 65100.0%
What portion of applicants met pre-screening criteria?
Did not meet criteria100.0%