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History of Changes for Study: NCT04003103
Safety and Pharmacokinetics of MK-8591 in Participants With Human Immunodeficiency Virus 1 (HIV-1) Infection (MK-8591-016)
Latest version (submitted August 24, 2022) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 June 27, 2019 None (earliest Version on record)
2 July 1, 2019 Study Status, Eligibility and Study Identification
3 August 6, 2019 Arms and Interventions, Outcome Measures, Study Status, Eligibility, Study Design, Study Description and Study Identification
4 August 13, 2019 Oversight and Study Status
5 September 27, 2019 Recruitment Status, Study Status and Contacts/Locations
6 October 3, 2019 Study Status and Contacts/Locations
7 October 15, 2019 Study Status and Contacts/Locations
8 November 12, 2019 Study Status and IPDSharing
9 December 4, 2019 Study Status and Contacts/Locations
10 December 13, 2019 Contacts/Locations and Study Status
11 February 19, 2020 Study Status
12 February 26, 2020 Contacts/Locations and Study Status
13 March 12, 2020 Study Status and Contacts/Locations
14 March 18, 2020 Contacts/Locations and Study Status
15 March 26, 2020 Contacts/Locations and Study Status
16 July 15, 2020 Contacts/Locations and Study Status
17 August 14, 2020 Contacts/Locations and Study Status
18 August 19, 2020 Contacts/Locations and Study Status
19 August 27, 2020 Contacts/Locations and Study Status
20 September 3, 2020 Contacts/Locations and Study Status
21 September 16, 2020 Study Status
22 September 30, 2020 Study Status
23 October 30, 2020 Study Status
24 December 8, 2020 Recruitment Status, Study Status, Contacts/Locations, Outcome Measures, Eligibility and Arms and Interventions
25 April 7, 2022 Study Status, Study Design and Study Identification
26 August 24, 2022 Study Status
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Study NCT04003103
Submitted Date:  June 27, 2019 (v1)

Open or close this module Study Identification
Unique Protocol ID: 8591-016
Brief Title: Safety and Pharmacokinetics of MK-8591 in Participants With Human Immunodeficiency Virus 1 (HIV-1) Infection (MK-8591-016)
Official Title: A Phase 2a, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Oral MK-8591 Once-Monthly in Participants at Low- Risk for HIV-1 Infection
Secondary IDs: Merck Protocol Number [MK-8591-016]
Open or close this module Study Status
Record Verification: June 2019
Overall Status: Not yet recruiting
Study Start: September 23, 2019
Primary Completion: April 5, 2021 [Anticipated]
Study Completion: April 5, 2021 [Anticipated]
First Submitted: June 27, 2019
First Submitted that
Met QC Criteria:
June 27, 2019
First Posted: July 1, 2019 [Actual]
Last Update Submitted that
Met QC Criteria:
June 27, 2019
Last Update Posted: July 1, 2019 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Merck Sharp & Dohme LLC
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: Yes
U.S. FDA-regulated Device: No
Data Monitoring: No
Open or close this module Study Description
Brief Summary: This study will evaluate the safety, tolerability, and pharmacokinetics (PK) of two doses of oral MK- 8591 compared with placebo in adults at low risk of HIV-1 infection.
Detailed Description:
Open or close this module Conditions
Conditions: HIV-1 Infection
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 2
Interventional Study Model: Parallel Assignment
Number of Arms: 3
Masking: Double (Participant, Investigator)
Allocation: Randomized
Enrollment: 250 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: MK-8591 60 mg
60 mg MK-8591 + placebo for MK-8591 administered once monthly, orally in capsule form for 24 weeks
Drug: MK-8591
MK-8591 administered orally in capsule form once monthly for 24 weeks
Drug: Placebo
Placebo for MK-8591 administered orally in capsule form once monthly for 24 weeks
Experimental: MK-8591 120 mg
120 mg MK-8591 administered once monthly, orally in capsule form for 24 weeks
Drug: MK-8591
MK-8591 administered orally in capsule form once monthly for 24 weeks
Placebo Comparator: Placebo
Placebo for MK-8591 administered once monthly, orally in capsule form for 24 weeks
Drug: Placebo
Placebo for MK-8591 administered orally in capsule form once monthly for 24 weeks
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Participants with an adverse event
[ Time Frame: Up to Week 24 ]

Percentage of participants with at least 1 adverse event (AE)
2. Participants who discontinued from study therapy
[ Time Frame: Up to week 20 ]

Percentage of participants who discontinued from study therapy due to an AE
3. Participants with a drug-related AE
[ Time Frame: Up to Week 24 ]

Percentage of participants with at least 1 drug-related AE
4. Participants with a serious adverse event
[ Time Frame: Up to Week 24 ]

Percentage of participants with at least 1 serious AE (SAE)
5. Participants with a Grade 3 to 5 AE
[ Time Frame: Up to Week 24 ]

Percentage of participants with at least 1 Grade 3 (severe AE) to 5 (death) AE
6. Participants with a serious and drug-related AE
[ Time Frame: Up to Week 24 ]

Percentage of participants with at least 1 AE which is both serious and drug-related
7. Participants with a Grade 3 to 5 and drug-related AE
[ Time Frame: Up to Week 24 ]

Percentage of participants with at least 1 AE which is both Grade 3 (severe AE) to 5 (death) AE and drug-related
8. Participants with an AE resulting in death
[ Time Frame: Up to Week 24 ]

Percentage of participants with an AE which results in death
Secondary Outcome Measures:
1. Area under the concentration-time curve of plasma MK-8591
[ Time Frame: Day 1 and Week 20, collect predose and 30-min postdose. On Day 2 collect ~24 hours after Day 1 dose. On Weeks 4, 8, 12 and 16, collect predose. Weeks 2, 3, 21, 22, 23 and 24: collect at any time during the study visit. ]

Area under the concentration-time curve (AUC) from time 0 to 672 hours post-dose of plasma MK-8591
2. Maximum concentration of plasma MK-8591
[ Time Frame: Day 1 and Week 20, collect predose and 30-min postdose. On Day 2 collect ~24 hours after Day 1 dose. On Weeks 4, 8, 12 and 16, collect predose. Weeks 2, 3, 21, 22, 23 and 24: collect at any time during the study visit. ]

Maximum concentration (Cmax) post-dose of plasma MK-8591
3. Trough concentration of plasma MK-8591
[ Time Frame: Day 1 and Week 20, collect predose and 30-min postdose. On Day 2 collect ~24 hours after Day 1 dose. On Weeks 4, 8, 12 and 16, collect predose. Weeks 2, 3, 21, 22, 23 and 24: collect at any time during the study visit. ]

Trough concentration (Ctrough) post-dose of plasma MK-8591
4. Apparent terminal half-life of plasma MK-8591
[ Time Frame: Day 1 and Week 20, collect predose and 30-min postdose. On Day 2 collect ~24 hours after Day 1 dose. On Weeks 4, 8, 12 and 16, collect predose. Weeks 2, 3, 21, 22, 23 and 24: collect at any time during the study visit. ]

Apparent terminal half-life (t1/2) post-dose of plasma MK-8591
5. AUC of MK-8591-triphosphate in peripheral blood mononuclear cells
[ Time Frame: Day 1, Day 2, Weeks 1, 2, 3, 4, 8, 12, 16, 20, 21, 22, 23, 24, 44, 52, 60, and 68 ]

AUC from time 0-672 hours post-dose of MK-8591-triphosphate in peripheral blood mononuclear cells (PBMCs)
6. Maximum concentration of MK-8591-triphosphate in PBMCs
[ Time Frame: Day 1, Day 2, Weeks 1, 2, 3, 4, 8, 12, 16, 20, 21, 22, 23, 24, 44, 52, 60, and 68 ]

Maximum concentration (Cmax) post-dose of MK-8591-triphosphate in PBMCs
7. Trough concentration of MK-8591-triphosphate in PBMCs
[ Time Frame: Day 1, Day 2, Weeks 1, 2, 3, 4, 8, 12, 16, 20, 21, 22, 23, 24, 44, 52, 60, and 68 ]

Trough concentration (Ctrough) post-dose of MK-8591-triphosphate in PBMCs
8. Apparent terminal half-life of MK-8591-triphosphate in PBMCs
[ Time Frame: Day 1, Day 2, Weeks 1, 2, 3, 4, 8, 12, 16, 20, 21, 22, 23, 24, 44, 52, 60, and 68 ]

Apparent terminal half-life (t1/2) post-dose of MK-8591-triphosphate in PBMCs
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age: 65 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
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
  • 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
  • Female has an acceptable Pap result documented within 36 months prior to screening.
  • Is currently using either an etonogestrel (ENG)-releasing implant (i.e. Nexplanon or Implanon NXT) or injectable medroxyprogesterone acetate (MPA).

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 MK-8591.
  • Female is expecting to conceive or donate eggs at any time during the study
  • Is unwilling to abstain from prohibited therapies
  • Female has carcinoma in situ of the cervix or invasive cervical cancer, or abnormalities of the vaginal mucosa or significant vaginal symptom(s), including but not limited to presence of any unresolved injury, and infectious or inflammatory condition of the local mucosa.
  • Female had a hysterectomy procedure and the cervix was removed (total hysterectomy).
Open or close this module Contacts/Locations
Study Officials: Medical Director
Study Director
Merck Sharp & Dohme LLC
Locations:
Open or close this module IPDSharing
Plan to Share IPD: Yes
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
Supporting Information:
Time Frame:
Access Criteria:
http://engagezone.msd.com/ds_documentation.php
URL:
Open or close this module References
Links:
Available IPD/Information:

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