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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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 |
Phase 1 |
Study Type: | Interventional |
Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: 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 |
- 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.
- 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 ]
Estimated Enrollment: | 21 |
Study Start Date: | October 2012 |
Estimated Study Completion Date: | October 2013 |
Estimated Primary Completion Date: | September 2013 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Experimental: MVC 300 mg
MVC 300 mg in unique dose
|
Drug: Maraviroc |
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.
![](https://webarchive.library.unt.edu/web/20130317075544im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
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
![](https://webarchive.library.unt.edu/web/20130317075544im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
Contact: Cecilia Cabrera, MD,PhD | 00 34 93 465 63 74 | CCabrera@irsicaixa.es |
Spain | |
Germans Trias i Pujol Hospital | Not yet recruiting |
Badalona, Barcelona, Spain, 08916 | |
Contact: Cecilia Cabrera, MD,PhD 0034 93 465 65 74 CCabrera@irxicaixa.es | |
Principal Investigator: Cecilia Cabrera, MD,PhD |
![](https://webarchive.library.unt.edu/web/20130317075544im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
No publications provided
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: | October 30, 2012 |
Health Authority: | Spain: Ministry of Health |
Keywords provided by Fundacio Lluita Contra la SIDA:
HIV, Maraviroc, PrEP, Ex vivo infection, rectal mucosa. |
Additional relevant MeSH terms:
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 |
ClinicalTrials.gov processed this record on March 14, 2013