NCT05494736 is a Phase 1 clinical trial of MK-8527 in Human Immunodeficiency Virus, sponsored by Merck Sharp & Dohme LLC.

Who is sponsoring NCT05494736?

NCT05494736 is sponsored by Merck Sharp & Dohme LLC.

What drugs are being tested in NCT05494736?

Interventions in NCT05494736: MK-8527.

What condition does NCT05494736 study?

NCT05494736 studies Human Immunodeficiency Virus.

Is NCT05494736 still recruiting?

NCT05494736 is currently completed. Last updated 26 March 2025.

Are results published for NCT05494736?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2025-03-26 · How we verify

NCT05494736

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

MK-8527 Single-Dose Trial in HIV-1 Infected Participants (MK-8527-004)

Completed Phase 1 Results posted Last updated 26 March 2025

What this trial tests

Phase 1 trial testing MK-8527 in Human Immunodeficiency Virus in 20 participants. Completed in 31 January 2024.

Timeline

17 November 2022

Primary endpoint
31 January 2024

31 January 2024

Quick facts

Lead sponsor	Merck Sharp & Dohme LLC
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	20
Start date	17 November 2022
Primary completion	31 January 2024
Estimated completion	31 January 2024
Sites	4 locations across Romania, South Africa

Drugs / interventions tested

MK-8527 — full drug profile →

Conditions studied

Human Immunodeficiency Virus — all drugs for Human Immunodeficiency Virus →

Sponsor

Merck Sharp & Dohme LLC — full company profile →

Who can join

Adults 18 to 60, any sex, with Human Immunodeficiency Virus. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change From Baseline in Plasma HIV-1 Ribonucleic Acid (RNA) Primary · Baseline and 168 hours postdose on Day 1

The mean change from baseline in HIV-1 RNA counts at 168 hours after a single doses of MK-8527 is reported.

Group	Value	95% CI
Panel A: MK-8527 1.0 mg	-1.38	-1.61 – -1.15
Panel B: MK-8527 0.5 mg	-1.40	-1.66 – -1.13
Panel C: MK-8527 0.25 mg	-0.80	-1.06 – -0.53

Number of Participants Experiencing ≥1 Adverse Event (AE) Primary · Up to 28 days

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.

Group	Value	95% CI
Panel A: MK-8527 1.0 mg	5
Panel B: MK-8527 0.5 mg	5
Panel C: MK-8527 0.25 mg	2

Number of Participants Discontinuing From Study Due to an AE Primary · Up to 28 days

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.

Group	Value	95% CI
Panel A: MK-8527 1.0 mg	0
Panel B: MK-8527 0.5 mg	0
Panel C: MK-8527 0.25 mg	0

Area Under the Concentration-Time Curve From Predose to 168 Hours Postdose (AUC0-168) of MK-8527 Triphosphate (MK-8527-TP) in Peripheral Blood Mononuclear Cells (PBMCs) Secondary · Predose and 4, 12, 24, 96, 120, 144, and 168 hours postdose

The AUC0-168 of MK-8527-TP in PBMCs is reported.

Group	Value	95% CI
Panel A: MK-8527 1.0 mg	29.2	24.1 – 35.3
Panel B: MK-8527 0.5 mg	12.6	10.1 – 15.7
Panel C: MK-8527 0.25 mg	5.53	4.44 – 6.89

Area Under the Concentration-Time Curve From Predose to Infinity (AUC0-inf) of MK-8527-TP in PBMCs Secondary · Predose and 4, 12, 24, 96, 120, 144, 168, 192, 240, 336, 504, and 672 hours postdose

The MK-8527-TP AUC0-inf in PBMCs is reported.

Group	Value	95% CI
Panel A: MK-8527 1.0 mg	47.7	37.8 – 60.3
Panel B: MK-8527 0.5 mg	24.5	18.7 – 32.1
Panel C: MK-8527 0.25 mg	8.87	6.60 – 11.9

Area Under the Concentration-Time Curve From Predose to Last Measurable Concentration (AUC0-last) of MK-8527-TP in PBMCs Secondary · Predose and 4, 12, 24, 96, 120, 144, 168, 192, 240, 336, 504, and 672 hours postdose

The MK-8527-TP AUC0-last in PBMCs is reported.

Group	Value	95% CI
Panel A: MK-8527 1.0 mg	40.9	32.5 – 51.4
Panel B: MK-8527 0.5 mg	17.1	13.1 – 22.2
Panel C: MK-8527 0.25 mg	5.88	4.51 – 7.66

Maximum Concentration (Cmax) of MK-8527-TP in PBMCs Secondary · Predose and 4, 12, 24, 96, 120, 144, 168, 192, 240, 336, 504, and 672 hours postdose

The MK-8527-TP Cmax in PBMCs is reported.

Group	Value	95% CI
Panel A: MK-8527 1.0 mg	0.270	0.232 – 0.314
Panel B: MK-8527 0.5 mg	0.134	0.113 – 0.160
Panel C: MK-8527 0.25 mg	0.0535	0.0449 – 0.0637

Concentration at 168 Hours Postdose (C168) of MK-8527-TP in PBMCs Secondary · 168 hours postdose

The C168 of MK-8527-TP in PBMCs is reported.

Group	Value	95% CI
Panel A: MK-8527 1.0 mg	0.111	0.0808 – 0.152
Panel B: MK-8527 0.5 mg	0.0484	0.0344 – 0.0681
Panel C: MK-8527 0.25 mg	0.0224	0.0154 – 0.0325

Time to Maximum Concentration (Tmax) of MK-8527-TP in PBMCs Secondary · Predose and 4, 12, 24, 96, 120, 144, 168, 192, 240, 336, 504, and 672 hours postdose

The MK-8527-TP Tmax in PBMCs is reported.

Group	Value	95% CI
Panel A: MK-8527 1.0 mg	24.00	12.00 – 24.05
Panel B: MK-8527 0.5 mg	24.03	12.07 – 24.68
Panel C: MK-8527 0.25 mg	23.91	12.00 – 24.12

Apparent Terminal Half-life (t½) of MK-8527-TP in PBMCs Secondary · Predose and 4, 12, 24, 96, 120, 144, 168, 192, 240, 336, 504, and 672 hours postdose

The apparent t½ of MK-8527-TP in PBMCs is reported.

Group	Value	95% CI
Panel A: MK-8527 1.0 mg	128.24	± 49.00
Panel B: MK-8527 0.5 mg	172.09	± 90.23
Panel C: MK-8527 0.25 mg	80.15	± 52.35

AUC0-inf of MK-8527 in Plasma Secondary · Predose and 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours postdose

The AUC0-inf of MK-8527 in plasma is reported.

Group	Value	95% CI
Panel A: MK-8527 1.0 mg	0.0512	0.0360 – 0.0728
Panel B: MK-8527 0.5 mg	NA	NA – NA
Panel C: MK-8527 0.25 mg	NA	NA – NA

AUC0-last of MK-8527 in Plasma Secondary · Predose and 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours postdose

The AUC0-last of MK-8527 in plasma is reported.

Group	Value	95% CI
Panel A: MK-8527 1.0 mg	0.0304	0.0221 – 0.0419
Panel B: MK-8527 0.5 mg	NA	NA – NA
Panel C: MK-8527 0.25 mg	NA	NA – NA

Adverse events — posted to ClinicalTrials.gov

Time frame: Up to 28 days. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Panel A: MK-8527 1.0 mg

Serious: 0/8 (0%)

Deaths: 0/8

Panel B: MK-8527 0.5 mg

Serious: 0/6 (0%)

Deaths: 0/6

Panel D: MK-8527 0.25 mg

Serious: 0/6 (0%)

Deaths: 0/6

Other adverse events (26 terms — click to expand)

Reaction	System	Panel A: MK-8527 1.0 mg	Panel B: MK-8527 0.5 mg	Panel D: MK-8527 0.25 mg
Headache	Nervous system disorders	—	—	—
Conjunctivitis allergic	Eye disorders	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—
Dyspepsia	Gastrointestinal disorders	—	—	—
Nausea	Gastrointestinal disorders	—	—	—
Vessel puncture site bruise	General disorders	—	—	—
Impetigo	Infections and infestations	—	—	—
Tinea faciei	Infections and infestations	—	—	—
Urinary tract infection	Infections and infestations	—	—	—
Carbuncle	Infections and infestations	—	—	—
Furuncle	Infections and infestations	—	—	—
Hordeolum	Infections and infestations	—	—	—
Respiratory syncytial virus infection	Infections and infestations	—	—	—
Rhinitis	Infections and infestations	—	—	—
Subcutaneous abscess	Infections and infestations	—	—	—
Viral rash	Infections and infestations	—	—	—
Contusion	Injury, poisoning and procedural complications	—	—	—
Procedural pain	Injury, poisoning and procedural complications	—	—	—
Skin abrasion	Injury, poisoning and procedural complications	—	—	—
Blood pressure increased	Investigations	—	—	—
Anogenital warts	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—
Dizziness	Nervous system disorders	—	—	—
Dyspnoea	Respiratory, thoracic and mediastinal disorders	—	—	—
Epistaxis	Respiratory, thoracic and mediastinal disorders	—	—	—
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	—	—	—
Dermatitis contact	Skin and subcutaneous tissue disorders	—	—	—

Data from ClinicalTrials.gov NCT05494736 adverse events section.

Sponsor's own description

This is a single-dose clinical study to evaluate the safety, tolerability, pharmacokinetics, and anti-retroviral activity of MK-8527 in antiretroviral therapy (ART)-naïve participants living with human immunodeficiency virus type 1 (HIV-1) infection. The primary hypothesis is that, at a dose that is safe and generally well tolerated, MK-8527 will have antiretroviral activity as measured by a reduction from baseline in plasma HIV-1 ribonucleic acid (RNA) of ≥1.0 log10 copies/mL. A total of 4 arms was initially planned but Arm D was never initiated as the primary objectives were achieved following completion of Arms A to C.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other trials of MK-8527

Trials testing the same drug.

NCT07528508 — A Clinical Trial in Healthy Participants to Study the Effect of a Single Dose of MK-8527 on Levels of Methadone (MK-8527 · Phase 1 · not yet recruiting
NCT07071623 — A Study of MK-8527 to Prevent Human Immunodeficiency Virus Type 1 (HIV-1) (MK-8527-010) · Phase 3 · recruiting
NCT07025551 — A Clinical Study of MK-8527 in Participants With Mild and Moderate Hepatic Impairment (MK-8527-015) · Phase 1 · completed
NCT07063238 — A Clinical Study of MK-8527 in Healthy Adult Participants (MK-8527-014) · Phase 1 · completed
NCT07044297 — A Clinical Study of MK-8527 to Prevent Human Immunodeficiency Virus Type 1 (HIV-1) (MK-8527-011) · Phase 3 · recruiting

Other recruiting trials for Human Immunodeficiency Virus

Currently open trials in the same condition.

NCT07530198 — HIV Therapeutic DNA Vaccine (ICVAX) Phase I Clinical Trial in Hong Kong · Phase 1 · recruiting
NCT06819176 — Lenacapavir Intensification to Disrupt HIV Reservoirs in Virologically Suppressed People With HIV Receiving Antiretrovir · Phase 1 · recruiting
NCT06408142 — Universal Test and Connect for HIV Service Delivery in South Africa · recruiting
NCT07101458 — The Eswatini PRISM Study on Adolescents Living With HIV · NA · recruiting
NCT06554223 — The SUSTAIN 2 Study - SUStained HIV Treatment for Adherence After Interruption in Care · NA · recruiting

Other Merck Sharp & Dohme LLC trials

Trials by the same sponsor.

NCT07224477 — A Clinical Study of V540A in Healthy Female Participants (V540A-005) · Phase 2 · not yet recruiting
NCT07302347 — A Study of Pembrolizumab in Japanese Pediatric Participants With Solid Tumors or Lymphomas and Japanese Adult Participan · Phase 1, PHASE2 · recruiting
NCT07528508 — A Clinical Trial in Healthy Participants to Study the Effect of a Single Dose of MK-8527 on Levels of Methadone (MK-8527 · Phase 1 · not yet recruiting
NCT07513376 — A Clinical Trial of Adjuvant Intismeran (V940) With or Without Pembrolizumab Coformulated With Berahyaluronidase Alfa (M · Phase 3 · not yet recruiting
NCT07532304 — A Clinical Trial of MK-4646 With Bictegravir/Emtricitabine/Tenofovir Alafenamide and Dolutegravir in Healthy Adult Parti · Phase 1 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05494736 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Merck Sharp & Dohme LLC
Last refreshed: 26 March 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05494736.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing