Study Comparing Two Alternatives of Antiretroviral Therapy as Post-exposure Prophylaxis to HIV-1: Tenofovir + Emtricitabine + Lopinavir/Ritonavir Versus Tenofovir + Emtricitabine + Raltegravir (RAL-PEP)
NCT ID: NCT01576731
Last Updated: 2015-04-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
240 participants
INTERVENTIONAL
2012-07-31
2014-07-31
Brief Summary
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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 high tolerability, a integrase inhibitor (raltegravir)could be an adequate drug for PEP.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Tenofovir + emtricitabine + lopinavir/r
Standard postexposure prophylaxis combination
Tenofovir, Emtricitabine, Lopinavir/r
Combination drug
Tenofovir + Emtricitabine + Raltegravir
new postexposure prophylaxis combination
Tenofovir, Emtricitabine, Raltegravir
Combination drug
Interventions
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Tenofovir, Emtricitabine, Lopinavir/r
Combination drug
Tenofovir, Emtricitabine, Raltegravir
Combination drug
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Source case with antiretroviral resistances
* any treatment contraindicated with the drugs of study
18 Years
ALL
Yes
Sponsors
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Hospital Clinic of Barcelona
OTHER
Responsible Party
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Felipe Garcia
MD
Principal Investigators
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Felipe Garcia, PhD
Role: PRINCIPAL_INVESTIGATOR
Consultant senior
Locations
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Hospital Clínic of Barcelona
Barcelona, Barcelona, Spain
Countries
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References
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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; RALPEP Study Group. A randomized clinical trial comparing ritonavir-boosted lopinavir versus raltegravir each with tenofovir plus emtricitabine for post-exposure prophylaxis for HIV infection. J Antimicrob Chemother. 2016 Jul;71(7):1987-93. doi: 10.1093/jac/dkw049. Epub 2016 Mar 18.
Other Identifiers
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2011-003799-35
Identifier Type: -
Identifier Source: org_study_id
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