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Antiretroviral

DOR/ISL for HIV

Phase 2
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 younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up pre-dose, and 0.5, 1, 2, 4, 8, 12, and 24 hours post-dose on day 28
Awards & highlights

Study Summary

This trial is testing a new drug combination to treat HIV-1 in children who are already on antiretroviral therapy or are treatment-naive. The primary purposes of the study are to examine the drug's pharmacokinetics and safety.

Eligible Conditions
  • HIV

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pre-dose, and 0.5, 1, 2, 4, 8, 12, and 24 hours post-dose on day 28
This trial's timeline: 3 weeks for screening, Varies for treatment, and pre-dose, and 0.5, 1, 2, 4, 8, 12, and 24 hours post-dose on day 28 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
AUC0-last of ISL-triphosphate (ISL-TP) in Peripheral Blood Mononuclear Cells (PBMCs)
Apparent Plasma Terminal Half-life (t½) of ISL
Apparent Total Clearance From Plasma (CL/F) of ISL
+8 more
Secondary outcome measures
Acceptability of DOR/ISL Tablet
Change From Baseline in CD4+ T-cells in TN Participants
Change From Baseline in Cluster of Differentiation 4+ (CD4+) T-cells in VS Participants
+6 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%
Sleep terror
7%
Oropharyngeal pain
7%
Alanine aminotransferase increased
7%
Humerus fracture
7%
Arthralgia
7%
Motor dysfunction
7%
Hypertension
7%
C-reactive protein increased
7%
Proteinuria
7%
Intermittent claudication
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: DOR/ISLExperimental Treatment1 Intervention
Pediatric participants with HIV-1 infection receive DOR/ISL for 96 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
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
4,582,093 Total Patients Enrolled
Merck Sharp & Dohme LLCLead Sponsor
3,892 Previous Clinical Trials
5,060,629 Total Patients Enrolled
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,777 Previous Clinical Trials
8,063,698 Total Patients Enrolled

Frequently Asked Questions

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

Under what circumstances is DOR/ISL typically prescribed?

"Patients with no doravirine resistance-associated mutations often find relief through the use of DOR/ISL. This drug combination is also useful in treating conditions like treatment failure, antiretroviral therapy naivety and other forms of antiretroviral therapies."

Answered by AI

How many individuals are receiving treatment through the current clinical trial?

"No, this trial has closed its recruitment process. It was first posted on November 26th 2020 and the last update occured on October 13th 2022. For those seeking alternative trials, there are 853 studies that seek patients with infections as well as 21 DOR/ISL clinical studies which remain open to participants."

Answered by AI

How many health care facilities are offering this research trial?

"This medical study is enrolling patients from four different sites, such as Emory Children's Center (Site 1805) in Atlanta and Duke University ( Site 1807) in Durham. Additionally, the Children's National Medical Center ( Site 1816) located in Washington is also participating."

Answered by AI

What are the chief aims of this clinical research?

"According to Merck Sharp & Dohme Corp., the primary metric of this trial is Apparent total clearance from plasma (CL/F) at Pre-dose, and 4 and 24 hours post-dose on Day 28. Additionally, secondary measurements include Percentage of VS participants with HIV-1 RNA ≥50 copies/mL determined by an Abbott Real Time PCR assay; Percentage of TN participants with HIV-1 RNA <50 copies/mL established via an Abbott Real Time PCR assay; as well as Change from baseline in CD4+ T-cells in VS participants evaluated through a central laboratory."

Answered by AI

Does the DOR/ISL treatment pose any hazards to recipients?

"In terms of safety, our team has assigned the drug DOR/ISL a score of 2. This is based on data from its Phase 2 trial which suggests that it is safe to use but there are yet no confirmed benefits associated with it."

Answered by AI

Is this experimental research the first of its kind?

"As of now, 21 studies surrounding DOR/ISL are underway in 146 cities and 27 nations. These efforts began back in 2014 when Merck Sharp & Dohme LLC conducted a Phase 3 clinical trial involving 769 participants. Subsequently, 19 more trials have been realized since the initial effort concluded."

Answered by AI

What prior investigations have employed DOR/ISL as a research tool?

"Presently, 21 clinical trials concerning DOR/ISL are underway. Of these studies, 9 have advanced to Phase 3 and they are mainly found in Cape Town, Western Cape. However, 348 locations globally provide this treatment regimen."

Answered by AI

Is access to this experiment still available for volunteers?

"The latest edit to this medical trial's information on clinicaltrials.gov indicates that it is not accepting new participants, despite initially being posted in November 2020. Nevertheless, 874 other trials are currently seeking volunteers for their research efforts."

Answered by AI
~10 spots leftby Apr 2025