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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

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ClinicalTrials.gov Identifier: NCT01719627
Recruitment Status : Completed
First Posted : November 1, 2012
Last Update Posted : March 5, 2015
Sponsor:
Information provided by (Responsible Party):
Fundacio Lluita Contra la SIDA

Study Description
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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).

Condition or disease Intervention/treatment Phase
HIV Drug: Maraviroc Drug: TVD 300/200 QD Phase 1

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
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: PILOT STUDY OF PROTECTION AGAINST ex Vivo HIV INFECTION IN RECTAL MUCOSA IN HEALTHY VOLUNTEERS AFTER ADMINISTRATION OF MARAVIROC
Study Start Date : October 2012
Actual Primary Completion Date : May 2014
Actual Study Completion Date : January 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
Drug Information available for: Maraviroc
U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
Experimental: MVC 300 mg
MVC 300 mg in unique dose
 Drug: Maraviroc
Unique dose of Maraviroc 300mg
Active Comparator: TVD 300/200 QD
TVD 300/200 QD during 7 days.
 Drug: TVD 300/200 QD
TVD 300/200 QD during 7 days
Experimental: Maraviroc 600mg
MVC 600mg in unique dose
 Drug: Maraviroc
Unique dose of Maraviroc 600mg


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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 Outcome Measures :
  1. Maraviroc plasmatic levels [ Time Frame: Visit 1 (Group 1: day 8, Group 2: day 7, Grop 3: day 9) ]
  2. Maraviroc levels in rectal mucosa [ Time Frame: Visit 1 (Group 1: day 8, Group 2: day 7, Grop 3: day 9) ]
  3. Truvada plasmatic levels [ Time Frame: Visit 1 (day 7) ]
  4. Truvada levels in rectal mucosa [ Time Frame: Visit 1 (day 7) ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01719627


Locations
Spain
Germans Trias i Pujol Hospital
Badalona, Barcelona, Spain, 08916
Sponsors and Collaborators
Fundacio Lluita Contra la SIDA
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Fundacio Lluita Contra la SIDA
ClinicalTrials.gov Identifier: NCT01719627     History of Changes
Other Study ID Numbers: MARAVIPREX
First Posted: November 1, 2012    Key Record Dates
Last Update Posted: March 5, 2015
Last Verified: March 2015

Keywords provided by Fundacio Lluita Contra la SIDA:
HIV, Maraviroc, PrEP, Ex vivo infection, rectal mucosa.

Additional relevant MeSH terms:
Infection
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
 Immune System Diseases
Slow Virus Diseases
Maraviroc
CCR5 Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents