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
1 other identifier
interventional
10
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 hiv
Started Oct 2012
Typical duration for phase_1 hiv
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2012
CompletedFirst Submitted
Initial submission to the registry
October 10, 2012
CompletedFirst Posted
Study publicly available on registry
November 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2015
CompletedMarch 5, 2015
March 1, 2015
1.6 years
October 10, 2012
March 4, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Infectivity of HIV: p24 production
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.
Baseline
Infectivity of HIV: p24 production
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.
Visit 1 (Group 1: day 8, Group 2: day 7, Grop 3: day 9)
Secondary Outcomes (4)
Maraviroc plasmatic levels
Visit 1 (Group 1: day 8, Group 2: day 7, Grop 3: day 9)
Maraviroc levels in rectal mucosa
Visit 1 (Group 1: day 8, Group 2: day 7, Grop 3: day 9)
Truvada plasmatic levels
Visit 1 (day 7)
Truvada levels in rectal mucosa
Visit 1 (day 7)
Study Arms (3)
MVC 300 mg
EXPERIMENTALMVC 300 mg in unique dose
TVD 300/200 QD
ACTIVE COMPARATORTVD 300/200 QD during 7 days.
Maraviroc 600mg
EXPERIMENTALMVC 600mg in unique dose
Interventions
Eligibility Criteria
You may qualify if:
- Men who have sex with men (MSM)
- Age 18 years or above
You may not qualify if:
- Existence of sexually transmitted infection (STI) or active systemic infection
- Submit a contraindication to rectal biopsy
- Take any drugs concomitantly with interactions with the MVC
- Subject unable to follow protocol
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Germans Trias i Pujol Hospital
Badalona, Barcelona, 08916, Spain
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 10, 2012
First Posted
November 1, 2012
Study Start
October 1, 2012
Primary Completion
May 1, 2014
Study Completion
January 1, 2015
Last Updated
March 5, 2015
Record last verified: 2015-03