Study Comparing Two Alternatives of Antiretroviral Therapy as Post-exposure Prophylaxis to HIV-1:FOVIR+EMTRICITABINA + LOPINAVIR/RITONAVIR VS TENOFOVIR+EMTRICITABINA + MARAVIROC (MARAVI-PEP)
Primary Purpose
HIV Infection
Status
Completed
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
Tenofovir, emtricitabine, maraviroc
Tenofovir, emtricitabine, lopinavir/r
Sponsored by

About this trial
This is an interventional prevention trial for HIV Infection focused on measuring HIV infection, Postexposure prophylaxis
Eligibility Criteria
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
Sites / Locations
- Hospital Clinic de Barcelona
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Tenofovir, emtricitabine, Maraviroc
Tenofovir, emtricitabine, lopinavir/r
Arm Description
New postexposure prophylaxis (it is a combination drug)
Standard prophylaxis (it is a combination drug)
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
NCT ID
NCT01533272
First Posted
February 8, 2012
Last Updated
March 31, 2015
Sponsor
Hospital Clinic of Barcelona
1. Study Identification
Unique Protocol Identification Number
NCT01533272
Brief Title
Study Comparing Two Alternatives of Antiretroviral Therapy as Post-exposure Prophylaxis to HIV-1:FOVIR+EMTRICITABINA + LOPINAVIR/RITONAVIR VS TENOFOVIR+EMTRICITABINA + MARAVIROC (MARAVI-PEP)
Official Title
Open Randomized Study Comparing Two Alternatives of Antiretroviral Therapy as Post-exposure Prophylaxis to HIV-1: TENOFOVIR+EMTRICITABINA + LOPINAVIR/RITONAVIR VS TENOFOVIR+EMTRICITABINA + MARAVIROC
Study Type
Interventional
2. Study Status
Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
February 2012 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
June 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Clinic of Barcelona
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infection
Keywords
HIV infection, Postexposure prophylaxis
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
240 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Tenofovir, emtricitabine, Maraviroc
Arm Type
Experimental
Arm Description
New postexposure prophylaxis (it is a combination drug)
Arm Title
Tenofovir, emtricitabine, lopinavir/r
Arm Type
Active Comparator
Arm Description
Standard prophylaxis (it is a combination drug)
Intervention Type
Drug
Intervention Name(s)
Tenofovir, emtricitabine, maraviroc
Intervention Description
experimental drug
Intervention Type
Drug
Intervention Name(s)
Tenofovir, emtricitabine, lopinavir/r
Intervention Description
Lopinavir/r 400mg BID
Primary Outcome Measure Information:
Title
Proportion of patients reaching 28 days of postexposure prophylaxis.
Description
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
Time Frame
28 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Felipe Garcia, PhD
Organizational Affiliation
Consultant
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Clinic de Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
12. IPD Sharing Statement
Citations:
PubMed Identifier
26994091
Citation
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.
Results Reference
derived
Learn more about this trial
Study Comparing Two Alternatives of Antiretroviral Therapy as Post-exposure Prophylaxis to HIV-1:FOVIR+EMTRICITABINA + LOPINAVIR/RITONAVIR VS TENOFOVIR+EMTRICITABINA + MARAVIROC (MARAVI-PEP)
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