Phase 2
Completed N=242
Safety and Pharmacokinetics of Oral Islatravir (MK-8591) Once Monthly in Participants at Low Risk of Human Immunodeficiency Virus 1 (HIV-1) Infection (MK-8591-016)
Source: ClinicalTrials.gov NCT04003103 ↗Enrolled (actual)
242
Serious AEs
0.4%
Results posted
Mar 2023
Primary outcomePrimary: Number of Participants With ≥1 Adverse Event (AE) Through Week 36 — 66; 63; 36 Participants
Summary
This study will evaluate the safety, tolerability and pharmacokinetics (PK) of 6 once-monthly doses of oral islatravir (60 mg and 120 mg) compared with placebo in adults at low risk of HIV-1 infection
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With ≥1 Adverse Event (AE) Through Week 36 |
66; 63; 36 | — |
| PRIMARY Number of Participants Discontinuing From Study Therapy Due to AE |
1; 1; 0 | — |
| PRIMARY Number of Participants Discontinuing From Study Therapy Due to ≥1 Drug-related AE |
1; 1; 0 | — |
| PRIMARY Number of Participants With ≥1 Drug-related AE Through Week 36 |
9; 14; 12 | — |
| PRIMARY Number of Participants With ≥1 Serious Adverse Event (SAE) Through Week 36 |
1; 0; 0 | — |
| PRIMARY Number of Participants With a ≥1 Grade 3 to Grade 5 AE up to Week 36 |
5; 4; 1 | — |
| PRIMARY Number of Participants With ≥1 Drug-related SAE Through Week 36 |
0; 0; 0 | — |
| PRIMARY Number of Participants With ≥1 Drug-related Grade 3 to 5 AE Through Week 36 |
0; 0; 0 | — |
| PRIMARY Number of Participants With an AE Resulting in Death Through Week 36 |
0; 0; 0 | — |
| SECONDARY Area Under the Plasma Concentration-time Curve From Dosing to 672 Hours Postdose (AUC0-672) of Plasma ISL |
7.88; 16.6; 21.2; 37.6 | — |
| SECONDARY Maximum Plasma Concentration (Cmax) of ISL |
0.387; 0.954; 0.376; 0.792 | — |
| SECONDARY Trough Plasma Concentration (Ctrough) of ISL |
0.000556; 0.00101; 0.000809; 0.000124 | — |
| SECONDARY Apparent Plasma Terminal Half-life (t1/2) of ISL |
NA; NA; 175; 177 | — |
| SECONDARY Number of Participants With ≥1 AE Through Week 24 |
58; 60; 32 | — |
| SECONDARY Number of Participants With ≥1 Drug-related AE Through Week 24 |
9; 14; 12 | — |
| SECONDARY Number of Participants With ≥1 SAE Through Week 24 |
1; 0; 0 | — |
| SECONDARY Number of Participants With a ≥1 Grade 3 to Grade 5 AE up to Week 24 |
3; 3; 1 | — |
| SECONDARY Number of Participants With ≥1 Drug-related SAE Through Week 24 |
0; 0; 0 | — |
| SECONDARY Number of Participants With ≥1 Drug-related Grade 3 to 5 AE Through Week 24 |
0; 0; 0 | — |
| SECONDARY Number of Participants With an AE Resulting in Death Through Week 24 |
0; 0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Is in general good health with acceptable laboratory values at screening
- Is confirmed HIV-uninfected based on negative HIV-1/HIV-2 test result before randomization
- Has low risk of HIV infection, within 12 months prior to screening visit or the rescreening visit (if applicable)
- Use contraceptives consistent with local regulations
- Female is not pregnant or breastfeeding, and is not a woman of childbearing potential (WOCBP)
- A WOCBP is using an acceptable contraceptive method, or is abstinent from heterosexual intercourse as their preferred and usual lifestyle; or has a negative pregnancy test.
Exclusion Criteria
- Has hypersensitivity or other contraindication to any of the components of the study interventions as determined by the investigator
- Has an active diagnosis of hepatitis due to any cause
- Has a history of malignancy ≤5 years prior to signing informed consent except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer.
- Is taking or is anticipated to require systemic immunosuppressive therapy, immune modulators, or any prohibited therapies from 30 days prior to Day
1 through the duration of the study.
- Is currently participating in or has participated in an interventional clinical study with an investigational compound or device within 30 days prior to Day1 through the duration of the study.
- Has previously been randomized in a study and received islatravir (MK-8591).
- Female is expecting to conceive or donate eggs at any time during the study
- Has QTc interval (using Fridericia correction) >450 msec (for males) or >460 msec (for females) or deemed clinically abnormal by the investigator.
Data sourced from ClinicalTrials.gov (NCT04003103). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.