Back to resultsStudy 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)
Primary Purpose
HIV Infection
Status
Completed
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
Tenofovir, Emtricitabine, Lopinavir/r
Tenofovir, Emtricitabine, Raltegravir
Sponsored by
About this trial
This is an interventional prevention trial for HIV Infection focused on measuring HIV Infection, Postexposure prophylaxis
Eligibility Criteria
Inclusion Criteria:
- Potentially sexual exposition to HIV
Exclusion Criteria:
- Pregnancy
- Source case with antiretroviral resistances
- any treatment contraindicated with the drugs of study
Sites / Locations
- Hospital Clínic of Barcelona
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Tenofovir + emtricitabine + lopinavir/r
Tenofovir + Emtricitabine + Raltegravir
Arm Description
Standard postexposure prophylaxis combination
new postexposure prophylaxis combination
Outcomes
Primary Outcome Measures
Proportion of patients dropping out before the 28 days of postexposure prophylaxis
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
Secondary Outcome Measures
Full Information
NCT ID
NCT01576731
First Posted
April 3, 2012
Last Updated
March 31, 2015
Sponsor
Hospital Clinic of Barcelona
1. Study Identification
Unique Protocol Identification Number
NCT01576731
Brief Title
Study Comparing Two Alternatives of Antiretroviral Therapy as Post-exposure Prophylaxis to HIV-1: Tenofovir + Emtricitabine + Lopinavir/Ritonavir Versus Tenofovir + Emtricitabine + Raltegravir (RAL-PEP)
Acronym
RAL-PEP
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 Type
Interventional
2. Study Status
Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
July 2012 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
July 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Clinic of Barcelona
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infection
Keywords
HIV Infection, Postexposure prophylaxis
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
240 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Tenofovir + emtricitabine + lopinavir/r
Arm Type
Active Comparator
Arm Description
Standard postexposure prophylaxis combination
Arm Title
Tenofovir + Emtricitabine + Raltegravir
Arm Type
Experimental
Arm Description
new postexposure prophylaxis combination
Intervention Type
Drug
Intervention Name(s)
Tenofovir, Emtricitabine, Lopinavir/r
Intervention Description
Combination drug
Intervention Type
Drug
Intervention Name(s)
Tenofovir, Emtricitabine, Raltegravir
Intervention Description
Combination drug
Primary Outcome Measure Information:
Title
Proportion of patients dropping out before the 28 days of postexposure prophylaxis
Description
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
Time Frame
28 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Potentially sexual exposition to HIV
Exclusion Criteria:
Pregnancy
Source case with antiretroviral resistances
any treatment contraindicated with the drugs of study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Felipe Garcia, PhD
Organizational Affiliation
Consultant senior
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Clínic of Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
12. IPD Sharing Statement
Citations:
PubMed Identifier
26994089
Citation
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.
Results Reference
derived
Learn more about this trial
Study Comparing Two Alternatives of Antiretroviral Therapy as Post-exposure Prophylaxis to HIV-1: Tenofovir + Emtricitabine + Lopinavir/Ritonavir Versus Tenofovir + Emtricitabine + Raltegravir (RAL-PEP)
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