Human Immunodeficiency Virus (HIV) InfectionPhase 1NCT04303156

Pharmacokinetics of Islatravir in Participants With Severe Renal Impairment (MK-8591-026)

A Phase 1 study testing Islatravir in people with Human Immunodeficiency Virus (HIV) Infection, run by Merck Sharp & Dohme LLC at 2 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study will evaluate the general tolerability and pharmacokinetics (PK) of a single 60 mg dose of MK-8591 (Islatravir) in participants with severe renal insufficiency, compared to participants in good health. Read more about this study

Who is it for?: Ages 18 to 75 yearsHealthy volunteers can take part
Conditions the study is for: Human Immunodeficiency Virus (HIV) Infection
What is being tested?: Islatravir
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 12 participants
Where: 2 sitesin 2 countries
Study dates: 18 Jun 2020to 19 Oct 2020
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Healthy participants must have the following:
Is in good health
Has a body mass index (BMI) ≥18.5 and ≤40 kg/m2.
Female is not pregnant or breastfeeding, and is not one of the following: a woman of childbearing potential (WOCBP); if a WOCBP, is using an acceptable contraceptive method, or is abstinent from heterosexual intercourse as their preferred and usual lifestyle; a WOCBP must have a negative highly sensitive pregnancy test within 24 hours before the first dose of study intervention
Renally impaired participants must have the following:
With the exception of renal impairment, is in generally good health
Has a BMI ≥ 18.5 and ≤ 40 kg/m2
Female is not pregnant or breastfeeding, and is not one of the following: a woman of childbearing potential (WOCBP); if a WOCBP, is using an acceptable contraceptive method, or is abstinent from heterosexual intercourse as their preferred and usual lifestyle; a WOCBP must have a negative highly sensitive pregnancy test within 24 hours before the first dose of study intervention

Who cannot join

Healthy participants must have the following:
Has a history of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases.
Is mentally or legally incapacitated, has significant emotional problems
Has known hypersensitivity to the active substance or any of the excipients of the study drug
Has a history of significant multiple and/or severe allergies (e.g. food, drug, latex allergy), or has had an anaphylactic reaction or significant intolerability (i.e. systemic allergic reaction) to prescription or non-prescription drugs or food.
Is positive for hepatitis B surface antigen, hepatitis C antibodies or HIV.

Show all 30Show fewer

Had major surgery, donated or lost 1 unit of blood (approximately 500 mL) within prior 4 weeks
Is taking medications to treat chronic medical conditions and/or conditions associated with renal disease
Has participated in another investigational study within prior 4 weeks
Other exclusions for healthy participants:
Does not agree to follow the smoking restrictions
Consumes greater than 1 glass for women, or 2 glasses for men of alcoholic beverages per day
Consumes excessive amounts,of caffeinated beverages per day.
Is a regular user of cannabis, any illicit drugs or has a history of drug (including alcohol) abuse within approximately prior 3 months.
Renally impaired participants must have the following:
Has a history or presence of renal artery stenosis.
Has had a renal transplant or nephrectomy.
Has rapidly fluctuating renal function as determined by historical measurements.
Has known hypersensitivity to the active substance or any of the excipients of the study drug.
Has a history of cancer (malignancy).
Has a history of significant multiple and/or severe allergies (e.g. food, drug, latex allergy), or has had an anaphylactic reaction or significant intolerability (i.e. systemic allergic reaction) to prescription or non-prescription drugs or food.
Is positive for hepatitis B surface antigen, hepatitis C antibodies or human immunodeficiency virus (HIV).
Had major surgery, donated or lost 1 unit of blood (approximately 500 mL) within 4 weeks prior to the prestudy (screening) visit.
Is taking medications to treat chronic medical conditions and/or conditions associated with renal disease and has not been on a stable regimen for at least 1 month and/or is unable to withhold the use of the medication(s) within 4 hours prior to and 8 hours after administration of the study drug.
Has participated in another investigational study within 4 weeks (or 5 half-lives, whichever is greater) prior to the prestudy (screening) visit.
Other exclusions for renally impaired participants
Does not agree to follow the smoking restrictions.
Consumes greater than 1 glass for women, or 2 glasses for men of alcoholic beverages per day.
Consumes excessive amounts of caffeinated beverages per day.
Is a regular user of cannabis, any illicit drugs or has a history of drug (including alcohol) abuse within approximately 3 months.

Trial locations and contacts

2 sites in 2 countries.

Country

City, postcode or hospital

2 sites in 2 countries

United States1 site

Clinical Pharmacology of Miami ( Site 0001)
Miami, Florida, 33014

Other trials in United States

Germany1 site

Charite Research Organisation GmbH ( Site 0003)
Berlin, 10117

Other trials in Germany

About this study

Official title: An Open-Label, Single-Dose Study to Evaluate the Pharmacokinetics of Islatravir (MK-8591) in Subjects With Severe Renal Impairment

Conditions: Human Immunodeficiency Virus (HIV) Infection
Being tested: Islatravir
Medical subject headings: Acquired Immunodeficiency Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

IslatravirDrug
Also called MK-8591
Single oral dose of 60 mg Islatravir administered in capsule form

Study groups in NCT04303156
Study group	Role	What they receive
Severe Renal Impairment	Experimental	Participants with severe renal impairment received a single oral dose of 60 mg MK-8591 (Islatravir) administered in capsule form. Receives: Drug: Islatravir
Healthy	Experimental	Healthy participants received a single oral dose of 60 mg Islatravir administered in capsule form. Receives: Drug: Islatravir

What is being measured

The primary outcome is the main question the study is designed to answer.

Area Under the Curve From Time 0 to Infinity (AUC0-inf) of Plasma Islatravir (ISL)
Participants were treated with islatravir (ISL), and blood samples were collected from pre-dose up to 168 hours post-dose to determine the concentration of plasma ISL. The 95% confidence interval was derived from a fixed effects model performed on natural log-transformed values.
Measured: Pre-dose, 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 168 hours post-dose
Area Under the Curve From Time 0 to Last Sampling Time (AUC0-last) of Plasma ISL
Participants were treated with ISL, and blood samples were collected from pre-dose up to 168 hours post-dose to determine the concentration of plasma ISL. The 95% confidence interval was derived from a fixed effects model performed on natural log-transformed values.
Measured: Pre-dose, 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 168 hours post-dose
Maximum Concentration (Cmax) of Plasma ISL
Participants were treated with ISL, and blood samples were collected from pre-dose up to 168 hours post-dose to determine the concentration of plasma ISL. The 95% confidence interval was derived from a fixed effects model performed on natural log-transformed values.
Measured: Pre-dose, 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 168 hours post-dose
Time of Maximum Concentration (Tmax) of Plasma ISL
Participants were treated with ISL, and blood samples were collected from pre-dose up to 168 hours post-dose to determine the concentration of plasma ISL. The Tmax of plasma ISL was expressed as a median.
Measured: Pre-dose, 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 168 hours post-dose
Apparent Terminal Half-life (t1/2) of Plasma ISL
Participants were treated with ISL, and blood samples were collected from pre-dose up to 168 hours post-dose to determine the concentration of plasma ISL. The Geometric Coefficient of Variation was expressed as a percent (%CV), and is calculated from the square root of corresponding estimated variance obtained for each population in fixed effect model multiplied by 100.
Measured: Pre-dose, 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 168 hours post-dose
Apparent Clearance (CL/F) of Plasma ISL
Participants were treated with ISL, and blood samples were collected from pre-dose up to 168 hours post-dose to determine the concentration of plasma ISL. The 95% confidence interval was derived from a fixed effects model performed on natural log-transformed values.
Measured: Pre-dose, 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 168 hours post-dose
Apparent Volume of Distribution (Vz/F) of Plasma ISL
Participants were treated with ISL, and blood samples were collected from pre-dose up to 168 hours post-dose to determine the concentration of plasma ISL. The 95% confidence interval was derived from a fixed effects model performed on natural log-transformed values.
Measured: Pre-dose, 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 168 hours post-dose

Secondary outcomes (10)

AUC0-inf of ISL Triphosphate (ISL-TP) in Peripheral Blood Mononuclear Cells (PBMC)
Participants were treated with ISL, and peripheral blood samples were collected from pre-dose up to 168 hours post-dose to determine the concentration of ISL-TP in PBMCs. The 95% confidence interval was derived from a fixed effects model performed on natural log-transformed values.
Measured: Pre-dose, 4, 24, 48, 96, 168 hours post-dose
AUC0-last of ISL-TP in PBMC
Participants were treated with ISL and peripheral blood samples were collected from pre-dose up to 168 hours post-dose to determine the concentration of ISL-TP in PBMCs. The 95% confidence interval was derived from a fixed effects model performed on natural log-transformed values.
Measured: Pre-dose, 4, 24, 48, 96, 168 hours post-dose
Cmax of ISL-TP in PBMC
Participants were treated with ISL and peripheral blood samples were collected from pre-dose up to 168 hours post-dose to determine the concentration of ISL-TP in PBMCs. The 95% confidence interval was derived from a fixed effects model performed on natural log-transformed values.
Measured: Pre-dose, 4, 24, 48, 96, 168 hours post-dose
Tmax of ISL-TP in PBMC
Participants were treated with ISL and peripheral blood samples were collected from pre-dose up to 168 hours post-dose to determine the concentration of ISL-TP in PBMCs. The Tmax of ISL-TP was expressed as a median.
Measured: Pre-dose, 4, 24, 48, 96, 168 hours post-dose
Concentration at 24 Hours Post Dose (C24) of ISL-TP in PBMC
Participants were treated with ISL and peripheral blood samples were collected at 24 hours post-dose to determine the concentration of ISL-TP in PBMCs. The 95% confidence interval was derived from a fixed effects model performed on natural log-transformed values.
Measured: 24 hours post-dose
Concentration at 168 Hours Post Dose (C168) of ISL-TP in PBMC
Participants were treated with ISL and peripheral blood samples were collected at 168 hours post-dose to determine the concentration of ISL-TP in PBMCs. The 95% confidence interval was derived from a fixed effects model performed on natural log-transformed values.
Measured: 168 hours post-dose
Concentration at 672 Hours Post Dose (C672) of ISL-TP in PBMC
Participants were treated with ISL and peripheral blood samples were collected at 672 hours post-dose to determine the concentration of ISL-TP in PBMCs. The 95% confidence interval was derived from a fixed effects model performed on natural log-transformed values.
Measured: 672 hours post-dose
T1/2 of ISL-TP in PBMC
Participants were treated with ISL, and blood samples were collected from pre-dose up to 168 hours post-dose to determine the concentration of ISL-TP in PBMCs. The t1/2 of plasma ISL was expressed as a geometric mean. The Geometric Coefficient of Variation was expressed as a percent (%CV), and is calculated from the square root of corresponding estimated variance obtained for each population in fixed effect model multiplied by 100.
Measured: Pre-dose, 4, 24, 48, 96, 168 hours post-dose
Percentage of Participants With an Adverse Event (AE)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.
Measured: Up to Day 29
Percentage of Participants Who Discontinued From the Study Due to an AE
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.
Measured: Up to Day 29

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

18 Jun 202019 Oct 2020

First posted10 Mar 2020
Study start18 Jun 2020
Primary completion19 Oct 2020
Study completion19 Oct 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Human Immunodeficiency Virus (HIV) InfectionStudies of the same condition, open and under way.
More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 12 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04303156
Sponsor's protocol ID: 8591-026
Other IDs: 2020-000153-27, MK-8591-026
Status last verified: Sep 2021
First submitted: 9 Mar 2020
Last updated: 28 Oct 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Publications

Matthews RP, Cao Y, Patel M, Weissler VL, Bhattacharyya A, De Lepeleire I, Last S, Rondon JC, Vargo R, Stoch SA, Iwamoto M. Safety and Pharmacokinetics of Islatravir in Individuals with Severe Renal Insufficiency. Antimicrob Agents Chemother. 2022 Dec 20;66(12):e0093122. doi: 10.1128/aac.00931-22. Epub 2022 Nov 8.
PubMed 36346229

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Human Immunodeficiency Virus (HIV) Infection trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-Label, Single-Dose Study to Evaluate the Pharmacokinetics of Islatravir (MK-8591) in Subjects With Severe Renal Impairment
ClinicalTrials.gov ID: NCT04303156
Acronym / sponsor ID: 8591-026
Conditions: Human Immunodeficiency Virus (HIV) Infection
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 12 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: 18 Jun 2020 (actual)
Primary completion: 19 Oct 2020 (actual)
Study completion: 19 Oct 2020 (actual)
First posted: 10 Mar 2020 (actual)
Results: Posted 28 Oct 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Severe Renal Impairment	Experimental	Drug: IslatravirParticipants with severe renal impairment received a single oral dose of 60 mg MK-8591 (Islatravir) administered in capsule form.
Healthy	Experimental	Drug: IslatravirHealthy participants received a single oral dose of 60 mg Islatravir administered in capsule form.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Is in good health
Has a body mass index (BMI) ≥18.5 and ≤40 kg/m2.
Female is not pregnant or breastfeeding, and is not one of the following: a woman of childbearing potential (WOCBP); if a WOCBP, is using an acceptable contraceptive method, or is abstinent from heterosexual intercourse as their preferred and usual lifestyle; a WOCBP must have a negative highly sensitive pregnancy test within 24 hours before the first dose of study intervention
With the exception of renal impairment, is in generally good health
Has a BMI ≥ 18.5 and ≤ 40 kg/m2

Key exclusion criteria (30 listed)

Has a history of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases.
Is mentally or legally incapacitated, has significant emotional problems
Has known hypersensitivity to the active substance or any of the excipients of the study drug
Has a history of significant multiple and/or severe allergies (e.g. food, drug, latex allergy), or has had an anaphylactic reaction or significant intolerability (i.e. systemic allergic reaction) to prescription or non-prescription drugs or food.
Is positive for hepatitis B surface antigen, hepatitis C antibodies or HIV.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
IslatravirAlso: MK-8591Single oral dose of 60 mg Islatravir administered in capsule form	Drug	Healthy, Severe Renal Impairment

Primary outcome

Area Under the Curve From Time 0 to Infinity (AUC0-inf) of Plasma Islatravir (ISL)
Time frame: Pre-dose, 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 168 hours post-dose
Participants were treated with islatravir (ISL), and blood samples were collected from pre-dose up to 168 hours post-dose to determine the concentration of plasma ISL. The 95% confidence interval was derived from a fixed effects model performed on natural log-transformed values.
Area Under the Curve From Time 0 to Last Sampling Time (AUC0-last) of Plasma ISL
Time frame: Pre-dose, 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 168 hours post-dose
Participants were treated with ISL, and blood samples were collected from pre-dose up to 168 hours post-dose to determine the concentration of plasma ISL. The 95% confidence interval was derived from a fixed effects model performed on natural log-transformed values.
Maximum Concentration (Cmax) of Plasma ISL
Time frame: Pre-dose, 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 168 hours post-dose
Participants were treated with ISL, and blood samples were collected from pre-dose up to 168 hours post-dose to determine the concentration of plasma ISL. The 95% confidence interval was derived from a fixed effects model performed on natural log-transformed values.
Time of Maximum Concentration (Tmax) of Plasma ISL
Time frame: Pre-dose, 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 168 hours post-dose
Participants were treated with ISL, and blood samples were collected from pre-dose up to 168 hours post-dose to determine the concentration of plasma ISL. The Tmax of plasma ISL was expressed as a median.
Apparent Terminal Half-life (t1/2) of Plasma ISL
Time frame: Pre-dose, 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 168 hours post-dose
Participants were treated with ISL, and blood samples were collected from pre-dose up to 168 hours post-dose to determine the concentration of plasma ISL. The Geometric Coefficient of Variation was expressed as a percent (%CV), and is calculated from the square root of corresponding estimated variance obtained for each population in fixed effect model multiplied by 100.
Apparent Clearance (CL/F) of Plasma ISL
Time frame: Pre-dose, 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 168 hours post-dose
Participants were treated with ISL, and blood samples were collected from pre-dose up to 168 hours post-dose to determine the concentration of plasma ISL. The 95% confidence interval was derived from a fixed effects model performed on natural log-transformed values.
Apparent Volume of Distribution (Vz/F) of Plasma ISL
Time frame: Pre-dose, 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 168 hours post-dose
Participants were treated with ISL, and blood samples were collected from pre-dose up to 168 hours post-dose to determine the concentration of plasma ISL. The 95% confidence interval was derived from a fixed effects model performed on natural log-transformed values.

10 secondary outcomes

AUC0-inf of ISL Triphosphate (ISL-TP) in Peripheral Blood Mononuclear Cells (PBMC)
Time frame: Pre-dose, 4, 24, 48, 96, 168 hours post-dose
AUC0-last of ISL-TP in PBMC
Time frame: Pre-dose, 4, 24, 48, 96, 168 hours post-dose
Cmax of ISL-TP in PBMC
Time frame: Pre-dose, 4, 24, 48, 96, 168 hours post-dose
Tmax of ISL-TP in PBMC
Time frame: Pre-dose, 4, 24, 48, 96, 168 hours post-dose
Concentration at 24 Hours Post Dose (C24) of ISL-TP in PBMC
Time frame: 24 hours post-dose
Concentration at 168 Hours Post Dose (C168) of ISL-TP in PBMC
Time frame: 168 hours post-dose
Concentration at 672 Hours Post Dose (C672) of ISL-TP in PBMC
Time frame: 672 hours post-dose
T1/2 of ISL-TP in PBMC
Time frame: Pre-dose, 4, 24, 48, 96, 168 hours post-dose
Percentage of Participants With an Adverse Event (AE)
Time frame: Up to Day 29
Percentage of Participants Who Discontinued From the Study Due to an AE
Time frame: Up to Day 29

Results and safety

Results posted to the registry on 28 Oct 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Severe Renal Impairment	6	6
Healthy	6	6

Primary outcome: Area Under the Curve From Time 0 to Infinity (AUC0-inf) of Plasma Islatravir (ISL)

Time frame: Pre-dose, 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 168 hours post-dose. Geometric mean (95% Confidence Interval). Unit: hr*μM

Measure	Severe Renal Impairment n = 6	Healthy n = 6
Value	14.4 (11.8 to 17.6)	6.54 (4.77 to 8.98)

Severe Renal Impairment vs Healthy: GMR: 2.20 (90% CI 1.68 to 2.88)

Population analysed: Participants who comply with the protocol sufficiently to ensure that generated data will be likely to exhibit the effects of treatment, according to the underlying scientific model. Compliance covers such considerations as exposure to treatment, availability of measurements and absence of important protocol deviations.

Primary outcome: Area Under the Curve From Time 0 to Last Sampling Time (AUC0-last) of Plasma ISL

Time frame: Pre-dose, 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 168 hours post-dose. Geometric mean (95% Confidence Interval). Unit: hr*μM

Measure	Severe Renal Impairment n = 6	Healthy n = 6
Value	11.0 (9.17 to 13.1)	5.68 (4.06 to 7.94)

Severe Renal Impairment vs Healthy: GMR: 1.93 (90% CI 1.46 to 2.55)

Primary outcome: Maximum Concentration (Cmax) of Plasma ISL

Time frame: Pre-dose, 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 168 hours post-dose. Geometric mean (95% Confidence Interval). Unit: μM

Measure	Severe Renal Impairment n = 6	Healthy n = 6
Value	1.23 (1.06 to 1.42)	1.19 (0.699 to 2.04)

Severe Renal Impairment vs Healthy: GMR: 1.03 (90% CI 0.67 to 1.57)

Primary outcome: Time of Maximum Concentration (Tmax) of Plasma ISL

Time frame: Pre-dose, 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 168 hours post-dose. Median (Full Range). Unit: Hours

Measure	Severe Renal Impairment n = 6	Healthy n = 6
Value	1.03 (1.00 to 2.00)	0.75 (0.5 to 1.00)

10 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse Events (AEs) from day of treatment (Day 1) up to day 29. All-cause mortality from day of randomization (Day 1) up to day 29.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Severe Renal Impairment	0 of 6 (0%)	1 of 6 (16.7%)	0 of 6
Healthy	0 of 6 (0%)	0 of 6 (0%)	0 of 6

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 36346229Matthews RP, Cao Y, Patel M, Weissler VL, Bhattacharyya A, De Lepeleire I, Last S, Rondon JC, Vargo R, Stoch SA, Iwamoto M. Safety and Pharmacokinetics of Islatravir in Individuals with Severe Renal Insufficiency. Antimicrob Agents Chemother. 2022 Dec 20;66(12):e0093122. doi: 10.1128/aac.00931-22. Epub 2022 Nov 8.
Individual participant dataSharing planned: Yes. http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Medical Director study director

Merck Sharp & Dohme LLC

2 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Islatravir in people with Human Immunodeficiency Virus (HIV) Infection, run by Merck Sharp & Dohme LLC at 2 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Oct 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Area Under the Curve From Time 0 to Infinity (AUC0-inf) of Plasma Islatravir (ISL) (time frame: Pre-dose, 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 168 hours post-dose). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04303156, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2021; AzTrials last refreshed its copy on 8 Nov 2026.