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Integrase Strand Transfer Inhibitor

Islatravir 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 older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 and day 140: predose and 30-min postdose. on day 2 collect ~24 hours after day 1 dose. on weeks 4, 8, 12 and 16, collect predose. weeks 1, 2, 3, 21, 22, 23 and 24: collect at any time during the study visit.
Awards & highlights

Study Summary

This trial will study the safety and how well the body tolerates and processes islatravir, a potential new HIV prevention drug, given monthly.

Eligible Conditions
  • HIV

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 and week 20, collect predose and 30-min postdose. on day 2 collect ~24 hours after day 1 dose. on weeks 4, 8, 12 and 16, collect predose. weeks 1, 2, 3, 21, 22, 23 and 24: collect at any time during the study visit.
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 and week 20, collect predose and 30-min postdose. on day 2 collect ~24 hours after day 1 dose. on weeks 4, 8, 12 and 16, collect predose. weeks 1, 2, 3, 21, 22, 23 and 24: collect at any time during the study visit. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants Discontinuing From Study Therapy Due to AE
Number of Participants Discontinuing From Study Therapy Due to ≥1 Drug-related AE
Number of Participants With a ≥1 Grade 3 to Grade 5 AE up to Week 36
+6 more
Secondary outcome measures
Apparent Plasma Terminal Half-life (t1/2) of ISL
Area Under the Plasma Concentration-time Curve From Dosing to 672 Hours Postdose (AUC0-672) of Plasma ISL
Maximum Plasma Concentration (Cmax) of ISL
+8 more

Side effects data

From 2022 Phase 2 trial • 242 Patients • NCT04003103
9%
Headache
7%
Nausea
5%
Blood pressure increased
4%
Diarrhoea
4%
Upper respiratory tract infection
3%
Abdominal pain
1%
Accidental overdose
100%
80%
60%
40%
20%
0%
Study treatment Arm
Islatravir 120 mg
Placebo
Islatravir 60 mg

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: Islatravir 60 mgExperimental Treatment2 Interventions
60 mg islatravir + placebo for islatravir administered once monthly, orally in capsule form for 24 weeks
Group II: Islatravir 120 mgExperimental Treatment1 Intervention
120 mg islatravir administered once monthly, orally in capsule form for 24 weeks
Group III: PlaceboPlacebo Group1 Intervention
Placebo for islatravir administered once monthly, orally in capsule form for 24 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Islatravir
2020
Completed Phase 2
~410
Placebo
1995
Completed Phase 3
~2670

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme Corp.Lead Sponsor
2,286 Previous Clinical Trials
4,582,041 Total Patients Enrolled
Merck Sharp & Dohme LLCLead Sponsor
3,888 Previous Clinical Trials
5,054,815 Total Patients Enrolled
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,777 Previous Clinical Trials
8,063,622 Total Patients Enrolled

Frequently Asked Questions

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

Is this survey open to geriatric patients?

"To qualify for this study, applicants must be between 18 and 65 years old. For those younger or older than the specified age range, there are respectively 215 trials and 676 trials available to them."

Answered by AI

How many participants are included in this medical experiment?

"At the moment, this research trial is no longer seeking participants. Initially posted on September 19th 2019 and most recently modified on August 24th 2022, any further inquiries should be directed elsewhere. There presently exists 851 studies searching for people with HIV-1 infection and 8 medical trials recruiting Islatravir patients."

Answered by AI

What are the eligibility parameters for participating in this medical research?

"This medical trial requires 242 participants aged 18-65 that are HIV-1 positive. Besides meeting the age criteria, applicants must also have a low risk of contracting HIV within the last year, be non pregnant or breastfeeding women not capable of bearing children (WOCBP) and using contraceptive methods or abstinent from intercourse as their primary lifestyle; plus get verified with an unfavorable pregnancy test result."

Answered by AI

What specific objectives is this experiment attempting to fulfill?

"The aim of this trial, to be conducted over a span of 68 weeks, is to identify and monitor serious adverse events. The secondary goals entail tracking the maximum concentration (Cmax) post-dose of plasma islatravir in participants, measuring percentage of patients with an AE resulting in death up to week 24, and evaluating the rate of any AEs amongst particpants within that same time frame."

Answered by AI

In which geographic regions does this research take place?

"Four centres are actively recruiting for this trial; Research Centers of America, LLC in Hollywood (Site 0007), Magee Womens Research Institute in Pittsburgh ( Site 0001), Johns Hopkins School of Medicine - Drug Development Unit located at Baltimore ( Site 0002) and four additional medical facilities."

Answered by AI

Is this experiment actively seeking participants?

"Unfortunately, recruitment for this experiment has been concluded. First posted on September 19th 2019, the last alteration was made to its posting on August 24th 2022. Nonetheless, those seeking clinical trials can find 851 studies recruiting patients with HIV-1 and 8 focused on Islatravir actively searching for participants."

Answered by AI

What potential harm could Islatravir pose to humans?

"Considering the Phase 2 status, it is estimated that Islatravir's safety can be rated as a 2 due to available evidence of its security but lack of data demonstrating effectiveness."

Answered by AI

Is this an unprecedented clinical trial?

"To date, 8 ongoing trials for Islatravir have been conducted in 133 cities and 25 countries. This drug was first tested as part of a Phase 2 study sponsored by Merck Sharp & Dohme Corp., which enrolled 242 participants back in 2019; since then a total of 18,326 studies have taken place."

Answered by AI

What researches have explored Islatravir's potential applications?

"Presently, there are 8 experimental studies utilizing Islatravir with 4 in the third phase of clinical trials. Most research sites for this drug can be found in Cape Town, Western Cape but globally 292 medical centres offer access to these treatments."

Answered by AI
~43 spots leftby Apr 2025