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 Overview
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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.

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

Conditions
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HIV Infection

Intervention / Treatment
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* Drug: Tenofovir, emtricitabine, maraviroc
* Drug: Tenofovir, emtricitabine, lopinavir/r


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV infection, Postexposure prophylaxis