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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

This study has suspended participant recruitment.
(Depending on results, study will be resumed or terminated)
Sponsor:
Information provided by (Responsible Party):
Fundacio Lluita Contra la SIDA
ClinicalTrials.gov Identifier:
NCT01719627
First received: October 10, 2012
Last updated: September 9, 2014
Last verified: September 2014

October 10, 2012
September 9, 2014
October 2012
April 2014   (final data collection date for primary outcome measure)
  • 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.
Same as current
Complete list of historical versions of study NCT01719627 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
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

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).

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.

Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
HIV
  • 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
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Suspended
21
January 2015
April 2014   (final data collection date for primary outcome measure)

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
Male
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT01719627
MARAVIPREX
No
Fundacio Lluita Contra la SIDA
Fundacio Lluita Contra la SIDA
Not Provided
Not Provided
Fundacio Lluita Contra la SIDA
September 2014

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