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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01533272
Recruitment Status : Completed
First Posted : February 15, 2012
Last Update Posted : April 1, 2015
Information provided by (Responsible Party):
Felipe Garcia, 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.

Condition or disease Intervention/treatment Phase
HIV Infection Drug: Tenofovir, emtricitabine, maraviroc Drug: Tenofovir, emtricitabine, lopinavir/r Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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 Start Date : February 2012
Actual Primary Completion Date : June 2014
Actual Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

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

Primary Outcome Measures :
  1. 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

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01533272

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Hospital Clinic de Barcelona
Barcelona, Spain, 08036
Sponsors and Collaborators
Hospital Clinic of Barcelona
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Principal Investigator: Felipe Garcia, PhD Consultant
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Felipe Garcia, PhD, Hospital Clinic of Barcelona Identifier: NCT01533272    
Other Study ID Numbers: MARAVI-PEP
First Posted: February 15, 2012    Key Record Dates
Last Update Posted: April 1, 2015
Last Verified: March 2015
Keywords provided by Felipe Garcia, Hospital Clinic of Barcelona:
HIV infection
Postexposure prophylaxis
Additional relevant MeSH terms:
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HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Antiviral Agents
Anti-Infective Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Anti-HIV Agents
HIV Protease Inhibitors
Protease Inhibitors
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors
HIV Fusion Inhibitors
Viral Fusion Protein Inhibitors
CCR5 Receptor Antagonists