Ignite Creation Date:
2025-12-24 @ 11:30 PM
Ignite Modification Date:
2026-01-11 @ 5:33 AM
Study NCT ID:
NCT02419456
Status:
COMPLETED
Last Update Posted:
2021-11-11
First Post:
2015-04-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pharmacokinetics of Two Intravaginal Rings (IVRs) Containing Different Dose Strengths of Vicriviroc (MK-4176) and MK-2048
Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Organization:
Study Overview
Official Title:
Phase 1 Pharmacokinetic Trial of Two Intravaginal Rings (IVRs) Containing Different Dose Strengths of Vicriviroc (MK-4176) and MK-2048
Status:
COMPLETED
Status Verified Date:
2016-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Intravaginal rings (IVRs) may offer an ideal way to deliver antiretroviral (ARV) drugs to prevent HIV infection. This study will evaluate the pharmacokinetics and safety of two IVRs containing different doses of a combination of two HIV ARV drugs, vicriviroc (VCV) (MK-4176) and MK-2048, in healthy, HIV-uninfected women.
Detailed Description:
The development of safe and effective HIV prevention strategies remains a global health priority. IVRs are currently being studied as a method to deliver HIV ARV drugs in women. This study will evaluate the pharmacokinetics and safety of two IVRs containing different doses of a combination of two HIV ARV drugs, vicriviroc (VCV) (MK-4176) and MK-2048, in healthy, HIV-uninfected women.
This study will enroll healthy, HIV-uninfected women, 18 to 45 years old. Participants will be randomly assigned to receive either the low dose MK-2048A IVR or the original dose MK-2048A IVR. Participants will receive their assigned IVR at the enrollment visit, and the IVR will be removed on Day 28. Participants will attend study visits at screening, enrollment (Day 0), and Days 1, 2, 3, 7, 14, 21, 28, 29, 30, 31, and 35. Study visits may include medical history reviews, physical examinations, blood collection, pelvic specimen collection, urine collection, and counseling and adherence assessments.
This study will enroll healthy, HIV-uninfected women, 18 to 45 years old. Participants will be randomly assigned to receive either the low dose MK-2048A IVR or the original dose MK-2048A IVR. Participants will receive their assigned IVR at the enrollment visit, and the IVR will be removed on Day 28. Participants will attend study visits at screening, enrollment (Day 0), and Days 1, 2, 3, 7, 14, 21, 28, 29, 30, 31, and 35. Study visits may include medical history reviews, physical examinations, blood collection, pelvic specimen collection, urine collection, and counseling and adherence assessments.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 12022 | REGISTRY | DAIDS-ES Registry Number | View |