First Study to Evaluate the Capacity of Maraviroc Drug to Protect Against HIV Infection in Samples of Rectal Mucosa From Healthy Volunteers
Primary Purpose
HIV
Status
Completed
Phase
Phase 1
Locations
Spain
Study Type
Interventional
Intervention
Maraviroc
TVD 300/200 QD
Maraviroc
Sponsored by
About this trial
This is an interventional health services research trial for HIV focused on measuring HIV, Maraviroc, PrEP, Ex vivo infection, rectal mucosa.
Eligibility Criteria
Inclusion Criteria:
- Men who have sex with men (MSM)
- Age 18 years or above
- HIV negative at the time of inclusion 4. Signed informed consent
Exclusion Criteria:
- 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
Sites / Locations
- Germans Trias i Pujol Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Experimental
Arm Label
MVC 300 mg
TVD 300/200 QD
Maraviroc 600mg
Arm Description
MVC 300 mg in unique dose
TVD 300/200 QD during 7 days.
MVC 600mg in unique dose
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Maraviroc plasmatic levels
Maraviroc levels in rectal mucosa
Truvada plasmatic levels
Truvada levels in rectal mucosa
Full Information
NCT ID
NCT01719627
First Posted
October 10, 2012
Last Updated
March 4, 2015
Sponsor
Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
1. Study Identification
Unique Protocol Identification Number
NCT01719627
Brief Title
First Study to Evaluate the Capacity of Maraviroc Drug to Protect Against HIV Infection in Samples of Rectal Mucosa From Healthy Volunteers
Official Title
PILOT STUDY OF PROTECTION AGAINST ex Vivo HIV INFECTION IN RECTAL MUCOSA IN HEALTHY VOLUNTEERS AFTER ADMINISTRATION OF MARAVIROC
Study Type
Interventional
2. Study Status
Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
October 2012 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
January 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV
Keywords
HIV, Maraviroc, PrEP, Ex vivo infection, rectal mucosa.
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MVC 300 mg
Arm Type
Experimental
Arm Description
MVC 300 mg in unique dose
Arm Title
TVD 300/200 QD
Arm Type
Active Comparator
Arm Description
TVD 300/200 QD during 7 days.
Arm Title
Maraviroc 600mg
Arm Type
Experimental
Arm Description
MVC 600mg in unique dose
Intervention Type
Drug
Intervention Name(s)
Maraviroc
Intervention Description
Unique dose of Maraviroc 300mg
Intervention Type
Drug
Intervention Name(s)
TVD 300/200 QD
Intervention Description
TVD 300/200 QD during 7 days
Intervention Type
Drug
Intervention Name(s)
Maraviroc
Intervention Description
Unique dose of Maraviroc 600mg
Primary Outcome Measure Information:
Title
Infectivity of HIV: p24 production
Description
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.
Time Frame
Baseline
Title
Infectivity of HIV: p24 production
Description
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.
Time Frame
Visit 1 (Group 1: day 8, Group 2: day 7, Grop 3: day 9)
Secondary Outcome Measure Information:
Title
Maraviroc plasmatic levels
Time Frame
Visit 1 (Group 1: day 8, Group 2: day 7, Grop 3: day 9)
Title
Maraviroc levels in rectal mucosa
Time Frame
Visit 1 (Group 1: day 8, Group 2: day 7, Grop 3: day 9)
Title
Truvada plasmatic levels
Time Frame
Visit 1 (day 7)
Title
Truvada levels in rectal mucosa
Time Frame
Visit 1 (day 7)
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Men who have sex with men (MSM)
Age 18 years or above
HIV negative at the time of inclusion 4. Signed informed consent
Exclusion Criteria:
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
Facility Information:
Facility Name
Germans Trias i Pujol Hospital
City
Badalona
State/Province
Barcelona
ZIP/Postal Code
08916
Country
Spain
12. IPD Sharing Statement
Learn more about this trial
First Study to Evaluate the Capacity of Maraviroc Drug to Protect Against HIV Infection in Samples of Rectal Mucosa From Healthy Volunteers
We'll reach out to this number within 24 hrs