Clinical Trials

MainTitle

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 been completed
Sponsor
Fundacio Lluita Contra la SIDA


Information provided by (Responsible Party)
Fundacio Lluita Contra la SIDA
ClinicalTrials.gov Identifier
NCT01719627

First received: October 10, 2012
Last updated: March 4, 2015
Last Verified: March 2015
History of Changes
Purpose

Purpose

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 Intervention Phase
HIV

Drug : Maraviroc
Drug : TVD 300/200 QD
Drug : Maraviroc
Phase 1

Study Type: Interventional
Study Design: 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

Further study details as provided by Fundacio Lluita Contra la SIDA:

Primary Outcome Measures

  • 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.
Secondary Outcome Measures:
  • 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) ]

Enrollment: 10
Study Start Date: October 2012
Study Completion Date: January 2015
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
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

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.

Eligibility

Eligibility

Ages Eligible for Study: 18 Years and older  
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

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01719627

Locations

Spain
Germans Trias i Pujol Hospital
Badalona, Barcelona, Spain, 08916

Sponsors and Collaborators

Fundacio Lluita Contra la SIDA
More Information

More Information


Responsible Party: Fundacio Lluita Contra la SIDA  
ClinicalTrials.gov Identifier: NCT01719627   History of Changes  
Other Study ID Numbers: MARAVIPREX  
Study First Received: October 10, 2012  
Last Updated: March 4, 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
Maraviroc

ClinicalTrials.gov processed this data on December 15, 2017
This information is provided by ClinicalTrials.gov.