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

Primary Outcome Measures:

• Infectivity of HIV: p24 production [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  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.
  
  
• Infectivity of HIV: p24 production [ Time Frame: Visit 1 (Group 1: day 8, Group 2: day 7, Grop 3: day 9) ] [ Designated as safety issue: No ]
  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 Outcome Measures:

• Maraviroc plasmatic levels [ Time Frame: Visit 1 (Group 1: day 8, Group 2: day 7, Grop 3: day 9) ] [ Designated as safety issue: No ]
  
• Maraviroc levels in rectal mucosa [ Time Frame: Visit 1 (Group 1: day 8, Group 2: day 7, Grop 3: day 9) ] [ Designated as safety issue: No ]
  
• Truvada plasmatic levels [ Time Frame: Visit 1 (day 7) ] [ Designated as safety issue: No ]
  
• Truvada levels in rectal mucosa [ Time Frame: Visit 1 (day 7) ] [ Designated as safety issue: No ]
  

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.