NCT01719627

First Study to Evaluate the Capacity of Maraviroc Drug to Protect Against HIV Infection in Samples of Rectal Mucosa From Healthy Volunteers

PILOT STUDY OF PROTECTION AGAINST ex Vivo HIV INFECTION IN RECTAL MUCOSA IN HEALTHY VOLUNTEERS AFTER ADMINISTRATION OF MARAVIROC

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Pre-exposure prophylaxis (PrEP) is a method of preventing HIV infection through the use of antiretroviral (ARV) medications before exposure to HIV. This study will assess the potential of MVC as a "on demand" pre-exposure prophylaxis, within a strategy for the prevention of HIV infection in men who have sex with men (MSM).

Detailed description

Several clinical trials are currently under way evaluating the safety and effectiveness of ARV-based PrEP for preventing HIV infection. The results of the first efficacy trials of ARV-based PrEP showed fewer HIV infections among study participants receiving the study drugs compared to those receiving placebo. Although the results are promising, concerns about adherence, pharmacokinetics, and toxicity still needs further exploration so new and more effective preventive pharmacological approaches should be evaluated. This trial will evaluate the safety, pharmacokinetics and efficacy of ex vivo HIV infection of rectal mucosa by the CCR5 antagonist drug maraviroc (Selzentry) administered to healthy volunteers. This trial will last approximately one year. Twenty-one volunteers will receive MVC 300 mg orally in a single dose. Study visits will occur at enrollment and at days 0, 7, 9, 14 and 16. All study visits will include a physical examination, blood collection and storage and in the basal visit and a day 7 or 9 the participants will undergo a colonoscopy. Ex vivo HIV infectivity in rectal mucosa biopsies and plasma/mucosa MVC levels will be evaluated.

Conditions

• HIV

Interventions

Type	Name	Description
DRUG	Maraviroc	Unique dose of Maraviroc 300mg
DRUG	TVD 300/200 QD	TVD 300/200 QD during 7 days
DRUG	Maraviroc	Unique dose of Maraviroc 600mg

Timeline

• Start date: 2012-10-01
• Primary completion: 2014-05-01
• Completion: 2015-01-01
• First posted: 2012-11-01
• Last updated: 2015-03-05

Locations

1 site across 1 country: Spain