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Pharmacokinetics of Two Intravaginal Rings (IVRs) Containing Different Dose Strengths of Vicriviroc (MK-4176) and MK-2048

HIV Infections Clinical Trial

Official title:
Phase 1 Pharmacokinetic Trial of Two Intravaginal Rings (IVRs) Containing Different Dose Strengths of Vicriviroc (MK-4176) and MK-2048

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02419456
Study type Interventional
Source National Institute of Allergy and Infectious Diseases (NIAID)
Contact
Status Completed
Phase Phase 1
Start date June 2015
Completion date March 2016
View Details
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