NCT01533272

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
240

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Feb 2012

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2012

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

February 8, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 15, 2012

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

April 1, 2015

Status Verified

March 1, 2015

Enrollment Period

2.3 years

First QC Date

February 8, 2012

Last Update Submit

March 31, 2015

Conditions

HIV Infection

Keywords

HIV infectionPostexposure prophylaxis

Outcome Measures

Primary Outcomes (1)

  • Proportion of patients reaching 28 days of postexposure prophylaxis.

    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

Study Arms (2)

Tenofovir, emtricitabine, Maraviroc

EXPERIMENTAL

New postexposure prophylaxis (it is a combination drug)

Drug: Tenofovir, emtricitabine, maraviroc

Tenofovir, emtricitabine, lopinavir/r

ACTIVE COMPARATOR

Standard prophylaxis (it is a combination drug)

Drug: Tenofovir, emtricitabine, lopinavir/r

Interventions

Tenofovir, emtricitabine, maravirocDRUG

experimental drug

Tenofovir, emtricitabine, Maraviroc
Tenofovir, emtricitabine, lopinavir/rDRUG

Lopinavir/r 400mg BID

Tenofovir, emtricitabine, lopinavir/r

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Clinic de Barcelona

Barcelona, Barcelona, 08036, Spain

Location

Related Publications (1)

  • Leal L, Leon A, Torres B, Inciarte A, Lucero C, Mallolas J, Laguno M, Martinez-Rebollar M, Gonzalez-Cordon A, Manzardo C, Rojas J, Pich J, Arnaiz JA, Gatell JM, Garcia F; MARAVIPEP Study Group. A randomized clinical trial comparing ritonavir-boosted lopinavir versus maraviroc each with tenofovir plus emtricitabine for post-exposure prophylaxis for HIV infection. J Antimicrob Chemother. 2016 Jul;71(7):1982-6. doi: 10.1093/jac/dkw048. Epub 2016 Mar 18.

    PMID: 26994091DERIVED

MeSH Terms

Conditions

HIV Infections

Interventions

TenofovirEmtricitabineMaraviroc

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Intervention Hierarchy (Ancestors)

OrganophosphonatesOrganophosphorus CompoundsOrganic ChemicalsAdeninePurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsTriazolesAzoles

Study Officials

  • Felipe Garcia, PhD

    Consultant

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

February 8, 2012

First Posted

February 15, 2012

Study Start

February 1, 2012

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

April 1, 2015

Record last verified: 2015-03

Locations

ES(1)