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

History of Changes

Tracking Information
First Received Date ^ICMJE	October 10, 2012
Last Updated Date	September 9, 2014
Start Date ^ICMJE	October 2012
Primary Completion Date	April 2014 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: October 30, 2012)	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.
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01719627 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: October 30, 2012)	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 ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	First Study to Evaluate the Capacity of Maraviroc Drug to Protect Against HIV Infection in Samples of Rectal Mucosa From Healthy Volunteers
Official Title ^ICMJE	PILOT STUDY OF PROTECTION AGAINST ex Vivo HIV INFECTION IN RECTAL MUCOSA IN HEALTHY VOLUNTEERS AFTER ADMINISTRATION OF MARAVIROC
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.
Study Type ^ICMJE	Interventional
Study Phase	Phase 1
Study Design ^ICMJE	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Health Services Research
Condition ^ICMJE	HIV
Intervention ^ICMJE	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
Study Arm (s)	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
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Suspended
Estimated Enrollment ^ICMJE	21
Estimated Completion Date	January 2015
Primary Completion Date	April 2014 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Male
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ^ICMJE	Spain
Removed Location Countries

Administrative Information
NCT Number ^ICMJE	NCT01719627
Other Study ID Numbers ^ICMJE	MARAVIPREX
Has Data Monitoring Committee	No
Responsible Party	Fundacio Lluita Contra la SIDA
Study Sponsor ^ICMJE	Fundacio Lluita Contra la SIDA
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Fundacio Lluita Contra la SIDA
Verification Date	September 2014
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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