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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01719627

Enrollment

Registered

2012-11-01

Start date

2012-10-31

Completion date

2015-01-31

Last updated

2015-03-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV

Keywords

HIV, Maraviroc, PrEP, Ex vivo infection, rectal mucosa.

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.

Interventions

DRUGMaraviroc

Unique dose of Maraviroc 300mg

DRUGTVD 300/200 QD

TVD 300/200 QD during 7 days

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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.

Secondary

Measure	Time frame
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 plasmatic levels	Visit 1 (day 7)
Truvada levels in rectal mucosa	Visit 1 (day 7)

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026