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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01719627
Recruitment Status : Completed
First Posted : November 1, 2012
Last Update Posted : March 5, 2015
Sponsor:
Information provided by (Responsible Party):
Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia

Tracking Information
First Submitted Date  ICMJE October 10, 2012
First Posted Date  ICMJE November 1, 2012
Last Update Posted Date March 5, 2015
Study Start Date  ICMJE October 2012
Actual Primary Completion Date May 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 30, 2012)
  • Infectivity of HIV: p24 production [ Time Frame: Baseline ]
    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) ]
    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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 4, 2015)
  • Maraviroc plasmatic levels [ Time Frame: Visit 1 (Group 1: day 8, Group 2: day 7, Grop 3: day 9) ]
  • Maraviroc levels in rectal mucosa [ Time Frame: Visit 1 (Group 1: day 8, Group 2: day 7, Grop 3: day 9) ]
  • Truvada plasmatic levels [ Time Frame: Visit 1 (day 7) ]
  • Truvada levels in rectal mucosa [ Time Frame: Visit 1 (day 7) ]
Original Secondary Outcome Measures  ICMJE
 (submitted: October 30, 2012)
  • Maraviroc plasmatic levels [ Time Frame: Visit 1 (Group 1: day 8, Group 2: day 7, Grop 3: day 9) ]
  • Maraviroc levels in rectal mucosa [ Time Frame: Visit 1 (Group 1: day 8, Group 2: day 7, Grop 3: day 9) ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE First Study to Evaluate the Capacity of Maraviroc Drug to Protect Against HIV Infection in Samples of Rectal Mucosa From Healthy Volunteers
Official Title  ICMJE PILOT STUDY OF PROTECTION AGAINST ex Vivo HIV INFECTION IN RECTAL MUCOSA IN HEALTHY VOLUNTEERS AFTER ADMINISTRATION OF MARAVIROC
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE HIV
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: MVC 300 mg
    MVC 300 mg in unique dose
    Intervention: Drug: Maraviroc
  • Active Comparator: TVD 300/200 QD
    TVD 300/200 QD during 7 days.
    Intervention: Drug: TVD 300/200 QD
  • Experimental: Maraviroc 600mg
    MVC 600mg in unique dose
    Intervention: Drug: Maraviroc
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 4, 2015)		 10
Original Estimated Enrollment  ICMJE
 (submitted: October 30, 2012)		 21
Actual Study Completion Date  ICMJE January 2015
Actual Primary Completion Date May 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01719627
Other Study ID Numbers  ICMJE MARAVIPREX
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
Study Sponsor  ICMJE Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
Verification Date March 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP