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

Phase 1

Completed

• Conditions: HIV
• Interventions: Drug: Maraviroc; Drug: TVD 300/200 QD

• Registration Number: NCT01719627
• Lead Sponsor: Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia

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 Timeline

• Study Start: 2012-10
• Study First Submitted: 2012-10-10
• Study First Submitted QC: 2012-10-30
• Study First Posted: 2012-11-01
• Primary Completion: 2014-05
• Study Completion: 2015-01
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-04
• Last Update Posted: 2015-03-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Maraviroc 600mg	Maraviroc	MVC 600mg in unique dose
TVD 300/200 QD	TVD 300/200 QD	TVD 300/200 QD during 7 days.
MVC 300 mg	Maraviroc	MVC 300 mg in unique dose

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Truvada plasmatic levels	Visit 1 (day 7)
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 levels in rectal mucosa	Visit 1 (day 7)

Trial Locations

Locations (1)

Germans Trias i Pujol Hospital; 🇪🇸 Badalona, Barcelona, Spain