← Back to Search

DOR/ISL for HIV

Q: What is the geographic scope of this investigation?

<p>Patients in Fort Pierce, <a href="https://www.withpower.com/clinical-trials/florida">Florida</a>; Decatur, <a href="https://www.withpower.com/clinical-trials/georgia">Georgia</a>; and West Palm Beach, <a href="https://www.withpower.com/clinical-trials/texas">Texas</a> are <a href="https://www.withpower.com/clinical-trials/all">all</a> eligible for participation at Midway Immunology and Research Center (Site 3009), <a href="https://www.withpower.com/clinical-trials/infectious-disease">Infectious disease</a> Specialists of Atlanta ( Site 3003) , Triple O Research Institute, P.A ( Site 3026). There are also 17 other sites which can be found on the study page.</p>

Phase 3

Waitlist Available

Research Sponsored by Merck Sharp & Dohme LLC

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 week 48 up to week 96

Awards & highlights

Study Summary

This trial will evaluate the safety and effectiveness of a new HIV treatment compared with the current one.

Who is the study for?

This trial is for adults with HIV-1 who are successfully managing their virus levels (below 50 copies/mL) on current ART regimens without any history of treatment failure. Women must either not be able to bear children or use reliable contraception and have a negative pregnancy test.Check my eligibility

What is being tested?

The study compares the safety and effectiveness of switching to Doravirine/Islatravir (DOR/ISL) versus continuing with existing ART at keeping HIV-1 RNA below detectable levels after 48 weeks, aiming to prove DOR/ISL is just as good.See study design

What are the potential side effects?

While specific side effects aren't listed here, common ones for antiretroviral drugs include nausea, headaches, tiredness, and potential liver issues. The trial will monitor participants closely for any adverse reactions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 48 up to week 96

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 48 up to week 96

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 48 up to week 96 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 with HIV-1 RNA ≥50 copies/mL at Week 48

Participants with an AE leading to discontinuation of study intervention at Week 48

Participants with one or more AEs at Week 48

Secondary outcome measures

Change from Day 1 in CD4+ T-cell count at Week 96

Change from Day 1 in cluster of differentiation 4+ (CD4+) T-cell count at Week 48

Change from Week 48 in CD4+ T-cell count at Week 96

+12 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%

Fatigue

14%

Headache

14%

Nausea

14%

Accidental overdose

14%

Rash

Intermittent claudication

Oropharyngeal pain

Alanine aminotransferase increased

Motor dysfunction

Hypertension

Humerus fracture

Proteinuria

Sleep terror

Haematuria

Arthralgia

C-reactive protein increased

Postoperative wound infection

Urinary tract infection

Pancytopenia

Memory impairment

Dry eye

Intestinal transit time increased

Eye irritation

Skin candida

Upper respiratory tract infection

Obesity

Anaemia

Chest pain

Exposure to communicable disease

Abdominal pain

Mitral valve incompetence

Pyrexia

Blood creatine phosphokinase increased

Amoebiasis

Blood calcium increased

Anaemia postoperative

Blood cholesterol increased

Respiratory tract infection viral

Device dislocation

Blood glucose increased

Myelopathy

Cough

Night sweats

Peripheral arterial occlusive disease

100%

80%

60%

40%

20%

Study treatment Arm

DOR+ART

DOR/ISL+ART

Placebo+ART

ISL+ART

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: DOR/ISLExperimental Treatment1 Intervention

Participants with HIV-1 that has been virologically suppressed for ≥3 consecutive months on a stable oral ART are treated with DOR/ISL for 96 weeks

Group II: ART + DOR/ISLActive Control2 Interventions

Participants with HIV-1 that has been virologically suppressed for ≥3 consecutive months on a stable oral ART are first treated with standard of care (SOC) ART for 48 weeks, followed by 48 weeks of treatment with DOR/ISL

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

DOR/ISL

2020

Completed Phase 3

~80

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme LLCLead Sponsor

3,886 Previous Clinical Trials

5,054,070 Total Patients Enrolled

Medical DirectorStudy DirectorMerck Sharp & Dohme LLC

2,777 Previous Clinical Trials

8,062,979 Total Patients Enrolled

Media Library

ART Clinical Trial Eligibility Overview. Trial Name: NCT05631093 — Phase 3

HIV Research Study Groups: ART + DOR/ISL, DOR/ISL

HIV Clinical Trial 2023: ART Highlights & Side Effects. Trial Name: NCT05631093 — Phase 3

ART 2023 Treatment Timeline for Medical Study. Trial Name: NCT05631093 — Phase 3

Frequently Asked Questions

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

Are new participants being accepted for this experiment?

"Reports on clinicaltrials.gov suggest that this experimental trial is actively seeking volunteers, having been first posted to the site on February 20th 2021 and last edited March 9th 2021."

Answered by AI

How many participants are currently trialing this therapy?

"Affirmative. A quick glance at clinicaltrials.gov reveals that this medical research is still open to participant enrollment, starting from February 20th, 2021 and updated as of March 9th 2022. 501 volunteers are sought after across 17 sites in total."

Answered by AI

What potential risks do patients need to be aware of when using DOR/ISL?

"With supporting evidence of efficacy and extensive safety data, our team at Power assigned DOR/ISL a score of 3 on the risk scale."

Answered by AI

What goals does this research endeavor intend to achieve?

"This research project, which is intended to span up to 48 weeks, has a primary aim of ascertaining the number of participants with HIV-1 RNA ≥50 copies/mL at Week 48. Additionally, secondary objectives include quantifying changes in CD4+ T-cell count from Day 1 at Week 96; determining percentages of patients with HIV-1 RNA <50 copies/mL and <200 copies/mL respectively by Week 48 and Week 96."

Answered by AI

What is the geographic scope of this investigation?

"Patients in Fort Pierce, Florida; Decatur, Georgia; and West Palm Beach, Texas are all eligible for participation at Midway Immunology and Research Center (Site 3009), Infectious disease Specialists of Atlanta ( Site 3003) , Triple O Research Institute, P.A ( Site 3026). There are also 17 other sites which can be found on the study page."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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)

2023. "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)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05631093.

All > Hiv