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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-31

Study Completion Date

2015-01-31

Brief Summary

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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).

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Detailed Description

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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

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HIV

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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MVC 300 mg

MVC 300 mg in unique dose

Group Type EXPERIMENTAL

Maraviroc

Intervention Type DRUG

Unique dose of Maraviroc 300mg

TVD 300/200 QD

TVD 300/200 QD during 7 days.

Group Type ACTIVE_COMPARATOR

TVD 300/200 QD

Intervention Type DRUG

TVD 300/200 QD during 7 days

Maraviroc 600mg

MVC 600mg in unique dose

Group Type EXPERIMENTAL

Maraviroc

Intervention Type DRUG

Unique dose of Maraviroc 600mg

Interventions

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Maraviroc

Unique dose of Maraviroc 300mg

Intervention Type DRUG

TVD 300/200 QD

TVD 300/200 QD during 7 days

Intervention Type DRUG

Maraviroc

Unique dose of Maraviroc 600mg

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Men who have sex with men (MSM)
2. Age 18 years or above
3. HIV negative at the time of inclusion 4. Signed informed consent

Exclusion Criteria

1. Existence of sexually transmitted infection (STI) or active systemic infection
2. Submit a contraindication to rectal biopsy
3. Take any drugs concomitantly with interactions with the MVC
4. Subject unable to follow protocol

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No