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

Phase 4

Completed

• Conditions: HIV Infection
• Interventions: Drug: Tenofovir, emtricitabine, lopinavir/r; Drug: Tenofovir, emtricitabine, maraviroc

• Registration Number: NCT01533272
• Lead Sponsor: Hospital Clinic of Barcelona

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-02
• Study First Submitted: 2012-02-08
• Study First Submitted QC: 2012-02-10
• Study First Posted: 2012-02-15
• Primary Completion: 2014-06
• Study Completion: 2014-06
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-31
• Last Update Posted: 2015-04-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 240

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tenofovir, emtricitabine, lopinavir/r	Tenofovir, emtricitabine, lopinavir/r	Standard prophylaxis (it is a combination drug)
Tenofovir, emtricitabine, Maraviroc	Tenofovir, emtricitabine, maraviroc	New postexposure prophylaxis (it is a combination drug)

Primary Outcome Measures

Name	Time	Method
Proportion of patients reaching 28 days of postexposure prophylaxis.	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

Trial Locations

Locations (1)

Hospital Clinic de Barcelona; 🇪🇸 Barcelona, Spain