Study Comparing Two Alternatives of Antiretroviral Therapy as Post-exposure Prophylaxis to HIV-1:FOVIR+EMTRICITABINA + LOPINAVIR/RITONAVIR VS TENOFOVIR+EMTRICITABINA + MARAVIROC (MARAVI-PEP)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-29

Study Completion Date

2014-06-30

Brief Summary

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As a measure of secondary prophylaxis, and with the final objective of avoiding the infection, it has been suggested to use antiretroviral therapy. This is known as post-exposure prophylaxis (PEP).

Although there are different recommendations, almost every guideline recommend using 3 drugs as PEP both in USA and Europe.

Toxicity is one of the main limitations of PEP. Side effects during PEP are very usual, are attributed mainly to PI and are the main reasons for poor adherence or lost of follow-up.

A current standard regimen is AZT+3TC (Combivir®) or tenofovir+emtricitabine (Truvada®) plus the PI lopinavir/r. Toxicity associated with this regimens are high (31-85% of cases), with a 10-35% interruption of PEP Maraviroc, a CCR5 receptor antagonist, very well tolerated, coul be an adequate drug for PEP.

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Detailed Description

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Conditions

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HIV Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Tenofovir, emtricitabine, Maraviroc

New postexposure prophylaxis (it is a combination drug)

Group Type EXPERIMENTAL

Tenofovir, emtricitabine, maraviroc

Intervention Type DRUG

experimental drug

Tenofovir, emtricitabine, lopinavir/r

Standard prophylaxis (it is a combination drug)

Group Type ACTIVE_COMPARATOR

Tenofovir, emtricitabine, lopinavir/r

Intervention Type DRUG

Lopinavir/r 400mg BID

Interventions

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Tenofovir, emtricitabine, maraviroc

experimental drug

Intervention Type DRUG

Tenofovir, emtricitabine, lopinavir/r

Lopinavir/r 400mg BID

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Both sexes
* Older than 18 years old
* A potentially sexual exposition to HIV
* Accept to participate

Exclusion Criteria

* Pregnant women
* The source case a person with HIV antiretroviral resistances
* Persons with a treatment that is contraindicated with the drugs in the study

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes