PILOT STUDY OF PROTECTION AGAINST ex Vivo HIV INFECTION IN RECTAL MUCOSA IN HEALTHY VOLUNTEERS AFTER ADMINISTRATION OF MARAVIROC
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- Infectivity of HIV: p24 production
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Men who have sex with men (MSM)
- •Age 18 years or above
- •HIV negative at the time of inclusion
- •Signed informed consent
Exclusion Criteria
- •Existence of sexually transmitted infection (STI) or active systemic infection
- •Submit a contraindication to rectal biopsy
- •Take any drugs concomitantly with interactions with the MVC
- •Subject unable to follow protocol
Arms & Interventions
MVC 300 mg
MVC 300 mg in unique dose
Intervention: Maraviroc (Drug)
TVD 300/200 QD
TVD 300/200 QD during 7 days.
Intervention: TVD 300/200 QD (Drug)
Maraviroc 600mg
MVC 600mg in unique dose
Intervention: Maraviroc (Drug)
Outcomes
Primary Outcomes
Infectivity of HIV: p24 production
Time Frame: Visit 1 (Group 1: day 8, Group 2: day 7, Grop 3: day 9)
HIV replication will be measured by the determination of HIV p24 production in culture supernatant after 12 days of culture. The HIV production in ex vivo cultures from the basal and after drug administration will be compared and the results will be expressed as a measure of Maraviroc efficacy.
Secondary Outcomes
- Truvada plasmatic levels(Visit 1 (day 7))
- Maraviroc plasmatic levels(Visit 1 (Group 1: day 8, Group 2: day 7, Grop 3: day 9))
- Maraviroc levels in rectal mucosa(Visit 1 (Group 1: day 8, Group 2: day 7, Grop 3: day 9))
- Truvada levels in rectal mucosa(Visit 1 (day 7))