NCT05494736CompletedPhase 1
MK-8527 Single-Dose Trial in HIV-1 Infected Participants (MK-8527-004)
A Single-Dose Clinical Trial to Study the Safety, Tolerability, Pharmacokinetics, and Anti-Retroviral Activity of MK-8527 Monotherapy in Anti-Retroviral Therapy (ART)-Naïve, HIV-1 Infected Participants
Source: ClinicalTrials.gov · Last updated 26 Mar 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 20 (actual)
- First submitted
- 2 Aug 2022
- Start date
- 17 Nov 2022
- Primary completion date
- 31 Jan 2024
- Lead sponsor
- Merck Sharp & Dohme LLC
- Diseases
- HIV
- NCT number
- NCT05494736
- EU CT number
- 2023-503682-39-00
- EudraCT number
- 2023-503682-39
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 20
- From 17 Nov 2022 to the primary completion date, 31 Jan 2024
- 4 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Is unable to refrain from or anticipates the use of any medication, including prescription and nonprescription drugs or herbal remedies beginning approximately 2 weeks (or 5 half-lives) prior to administration of the initial dose of study intervention, throughout the study, until the poststudy visit
- Has participated in another investigational study within 4 weeks (or 5 half-lives, whichever is greater) prior to the prestudy (screening) visit
Other illness
- Has a history of clinically significant endocrine, GI, cardiovascular, hematological, hepatic, immunological (outside of HIV-1 infection), renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases
Who the study is looking for
- Is in good health other than HIV-1 infection
- Is documented HIV-1 positive
- Is ART-naïve, which is defined as not having received any marketed antiretroviral agent for treatment of HIV-1 infection (prior use of an ART for PrEP or investigational therapy is permitted if the last dose was ≥30 days prior to study drug administration)
- Is willing to receive no other ART for the monitoring period of this study
Age in the registry: 18 years to 60 years · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Institutul National de Boli Infectioase "Prof.Dr. Matei Bals" Coordinator of this site? Confirm its status | Bucharest | Romania | Completed |
| Josha Research ( Site 0003) Coordinator of this site? Confirm its status | Bloemfontein | South Africa | Unknown status |
| Desmond Tutu Health Foundation ( Site 0001) Coordinator of this site? Confirm its status | Cape Town | South Africa | Unknown status |
| Helen Joseph Hospital-Clinical HIV Research Unit ( Site 0002) Coordinator of this site? Confirm its status | Johannesburg | South Africa | Unknown status |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.