Study Comparing Two Alternatives of Antiretroviral Therapy as Post-exposure Prophylaxis to HIV-1: Tenofovir + Emtricitabine + Lopinavir/Ritonavir Versus Tenofovir + Emtricitabine + Raltegravir (RAL-PEP) (RAL-PEP)

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 high tolerability, a integrase inhibitor (raltegravir)could be an adequate drug for PEP.

Condition or disease	Intervention/treatment	Phase
HIV Infection	Drug: Tenofovir, Emtricitabine, Lopinavir/r; Drug: Tenofovir, Emtricitabine, Raltegravir	Phase 4

Study Design

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 + Emtricitabine + Lopinavir/Ritonavir Versus Tenofovir + Emtricitabine + Raltegravir
Study Start Date :	July 2012
Actual Primary Completion Date :	July 2014
Actual Study Completion Date :	July 2014

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Active Comparator: Tenofovir + emtricitabine + lopinavir/r; Standard postexposure prophylaxis combination	Drug: Tenofovir, Emtricitabine, Lopinavir/r; Combination drug
Experimental: Tenofovir + Emtricitabine + Raltegravir; new postexposure prophylaxis combination	Drug: Tenofovir, Emtricitabine, Raltegravir; Combination drug

Outcome Measures

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Primary Outcome Measures :

1. Proportion of patients dropping out before the 28 days of postexposure prophylaxis [ Time Frame: 28 days ]
   Proportion of patients droppping out before the 28 days of postexposure prophylaxis considering death, lost to folow-up and stopping or changing treatment for any reason

Eligibility Criteria

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

Criteria

Inclusion Criteria:

• Potentially sexual exposition to HIV

Exclusion Criteria:

• Pregnancy
• Source case with antiretroviral resistances
• any treatment contraindicated with the drugs of study

Contacts and Locations

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Locations

Spain
Hospital Clínic of Barcelona
Barcelona, Spain, 08036

Sponsors and Collaborators

Hospital Clinic of Barcelona

Investigators

Principal Investigator:	Felipe Garcia, PhD	Consultant senior

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Leal L, León A, Torres B, Inciarte A, Lucero C, Mallolas J, Laguno M, Martínez-Rebollar M, González-Cordón A, Manzardo C, Rojas J, Pich J, Arnaiz JA, Gatell JM, García 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.

Responsible Party:	Felipe Garcia, MD, Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier:	NCT01576731 History of Changes
Other Study ID Numbers:	2011-003799-35
First Posted:	April 12, 2012
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:

HIV Infections; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Ritonavir; Lopinavir; Tenofovir; Raltegravir Potassium; Emtricitabine	HIV Protease Inhibitors; Protease Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Anti-HIV Agents; Anti-Retroviral Agents; Antiviral Agents; Anti-Infective Agents; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inhibitors; Reverse Transcriptase Inhibitors; Nucleic Acid Synthesis Inhibitors; HIV Integrase Inhibitors; Integrase Inhibitors