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

Phase 4

Completed

• Conditions: HIV Infection
• Interventions: Drug: Tenofovir, Emtricitabine, Raltegravir; Drug: Tenofovir, Emtricitabine, Lopinavir/r

• Registration Number: NCT01576731
• Lead Sponsor: Hospital Clinic of Barcelona

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-04-03
• Study First Submitted QC: 2012-04-11
• Study First Posted: 2012-04-12
• Study Start: 2012-07
• Primary Completion: 2014-07
• Study Completion: 2014-07
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-31
• Last Update Posted: 2015-04-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 240

Inclusion Criteria

• Potentially sexual exposition to HIV

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tenofovir + Emtricitabine + Raltegravir	Tenofovir, Emtricitabine, Raltegravir	new postexposure prophylaxis combination
Tenofovir + emtricitabine + lopinavir/r	Tenofovir, Emtricitabine, Lopinavir/r	Standard postexposure prophylaxis combination

Primary Outcome Measures

Name	Time	Method
Proportion of patients dropping out before the 28 days of postexposure prophylaxis	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

Trial Locations

Locations (1)

Hospital Clínic of Barcelona; 🇪🇸 Barcelona, Spain