Study Comparing Two Alternatives of Antiretroviral Therapy as Post-exposure Prophylaxis to HIV-1: Tenofovir + Emtricitabine + Lopinavir/Ritonavir Versus Tenofovir + Emtricitabine + Raltegravir (RAL-PEP)
Information source: Hospital Clinic of Barcelona
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: HIV Infection
Intervention: Tenofovir, Emtricitabine, Lopinavir/r (Drug); Tenofovir, Emtricitabine, Raltegravir (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Hospital Clinic of Barcelona Official(s) and/or principal investigator(s): Felipe Garcia, PhD, Principal Investigator, Affiliation: Consultant senior
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.
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Primary outcome: Proportion of patients dropping out before the 28 days of postexposure prophylaxis
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Potentially sexual exposition to HIV
Exclusion Criteria:
- Pregnancy
- Source case with antiretroviral resistances
- any treatment contraindicated with the drugs of study
Locations and Contacts
Hospital Clínic of Barcelona, Barcelona 08036, Spain
Additional Information
Starting date: July 2012
Last updated: March 31, 2015
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