First Study to Evaluate the Capacity of Maraviroc Drug to Protect Against HIV Infection in Samples of Rectal Mucosa From Healthy Volunteers

• Sponsor: Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia (Other)
• Overall Status: Completed
• CT.gov ID: NCT01719627
• Collaborator: (none)
• Enrollment: 10
• Location: 1
• Arms: 3
• Duration (Months): 27
• Patients Per Site Per Month: 0.4

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
HIV	Drug: Maraviroc; Drug: TVD 300/200 QD; Drug: Maraviroc	Phase 1

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 Design

• Study Type: Interventional
• Actual Enrollment: 10 participants
• 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
• Study Start Date: Oct 1, 2012
• Actual Primary Completion Date: May 1, 2014
• Actual Study Completion Date: Jan 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

1. Infectivity of HIV: p24 production [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.

2. Infectivity of HIV: p24 production [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

1. Maraviroc plasmatic levels [Visit 1 (Group 1: day 8, Group 2: day 7, Grop 3: day 9)]

2. Maraviroc levels in rectal mucosa [Visit 1 (Group 1: day 8, Group 2: day 7, Grop 3: day 9)]

3. Truvada plasmatic levels [Visit 1 (day 7)]

4. Truvada levels in rectal mucosa [Visit 1 (day 7)]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Germans Trias i Pujol Hospital	Badalona	Barcelona	Spain	08916

Sponsors and Collaborators

• Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
• ClinicalTrials.gov Identifier: NCT01719627
• Other Study ID Numbers: MARAVIPREX
• First Posted: Nov 1, 2012
• Last Update Posted: Mar 5, 2015
• Last Verified: Mar 1, 2015

• Keywords provided by Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia: HIV, Maraviroc, PrEP, Ex vivo infection, rectal mucosa.
• Additional relevant MeSH terms: Infections; HIV Infections; Maraviroc

Study Results

No Results Posted as of Mar 5, 2015