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

HIV Clinical Trial

Official title:

PILOT STUDY OF PROTECTION AGAINST ex Vivo HIV INFECTION IN RECTAL MUCOSA IN HEALTHY VOLUNTEERS AFTER ADMINISTRATION OF MARAVIROC

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01719627
• Other study ID #: MARAVIPREX
• Status: Completed
• Phase: Phase 1
• First received: October 10, 2012
• Last updated: March 4, 2015
• Start date: October 2012
• Est. completion date: January 2015

Study information

• Verified date: March 2015
• Source: Fundacio Lluita Contra la SIDA
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ministry of Health
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: January 2015
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• HIV
• HIV Infections

Intervention

Drug:
• Maraviroc
Unique dose of Maraviroc 300mg
• TVD 300/200 QD
TVD 300/200 QD during 7 days
• Maraviroc
Unique dose of Maraviroc 600mg

Locations

Country	Name	City	State
Spain	Germans Trias i Pujol Hospital	Badalona	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Fundacio Lluita Contra la SIDA

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline	No
Primary	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.	Visit 1 (Group 1: day 8, Group 2: day 7, Grop 3: day 9)	No
Secondary	Maraviroc plasmatic levels		Visit 1 (Group 1: day 8, Group 2: day 7, Grop 3: day 9)	No
Secondary	Maraviroc levels in rectal mucosa		Visit 1 (Group 1: day 8, Group 2: day 7, Grop 3: day 9)	No
Secondary	Truvada plasmatic levels		Visit 1 (day 7)	No
Secondary	Truvada levels in rectal mucosa		Visit 1 (day 7)	No