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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

Page last updated: August 20, 2015

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