At a glance
ClinicalIndex Comparison Record- ✓Documented HIV-1 positive
- ✓ART-naïve (no prior marketed antiretroviral agents for HIV treatment; prior PrEP or investigational ART allowed if ≥30 days since last dose)
- ✓Willing to receive no other ART during the monitoring period
- ✓In good health other than HIV-1 infection
- ✕History of clinically significant endocrine, GI, cardiovascular, hematological, hepatic, immunological (outside HIV-1), renal, respiratory, genitourinary, or major neurological abnormalities or diseases
- ✕Unable to refrain from medications (prescription, nonprescription, herbal) from ~2 weeks or 5 half-lives before dosing through poststudy visit
- ✕Participated in another investigational study within 4 weeks or 5 half-lives (whichever is greater) prior to screening
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 1 clinical trial evaluating MK-8527 for Human Immunodeficiency Virus. Completed, enrolled 20 participants across 4 sites in 2 countries.
Detailed Summary
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.
Study Details
Timeline
Interventions
MK-8527 capsule taken by mouth.