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

March 31, 2015 updated by: Felipe Garcia, Hospital Clinic of Barcelona

Open Randomized Study Comparing Two Alternatives of Antiretroviral Therapy as Post-exposure Prophylaxis to HIV-1: TENOFOVIR+EMTRICITABINA + LOPINAVIR/RITONAVIR VS TENOFOVIR+EMTRICITABINA + MARAVIROC

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

240

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain, 08036
        • Hospital Clinic De Barcelona

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Tenofovir, emtricitabine, Maraviroc
New postexposure prophylaxis (it is a combination drug)
Drug: Tenofovir, emtricitabine, maraviroc
experimental drug
Active Comparator: Tenofovir, emtricitabine, lopinavir/r
Standard prophylaxis (it is a combination drug)
Drug: Tenofovir, emtricitabine, lopinavir/r
Lopinavir/r 400mg BID

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of patients reaching 28 days of postexposure prophylaxis.
Time Frame: 28 days
Postexposure prophylaxis has to be used during 28 days to have effectiveness. It is thought that a shorter period of treatment does not prevent HIV infection according to animal models. Therefore, we will assess the proportion of patients who complete the total period of treatment in each arm of the study. The hypothesis is that a higher proportion of patients who take the medication with lower side effects will complete the 28 days of postexposure prophylaxis
28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Clinic of Barcelona

Investigators

  • Principal Investigator: Felipe Garcia, PhD, Consultant

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2012

Primary Completion (Actual)

June 1, 2014

Study Completion (Actual)

June 1, 2014

Study Registration Dates

First Submitted

February 8, 2012

First Submitted That Met QC Criteria

February 10, 2012

First Posted (Estimate)

February 15, 2012

Study Record Updates

Last Update Posted (Estimate)

April 1, 2015

Last Update Submitted That Met QC Criteria

March 31, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MARAVI-PEP

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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