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

Hospital Clinic of Barcelona

Status and phase: Completed; Phase 4

Conditions: HIV Infection

Treatments: Drug: Tenofovir, Emtricitabine, Raltegravir; Drug: Tenofovir, Emtricitabine, Lopinavir/r

Study type: Interventional

Funder types: Other

Identifiers

NCT01576731

2011-003799-35

Details and patient eligibility

About

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.

Enrollment: 240 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Potentially sexual exposition to HIV

Exclusion criteria

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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240 participants in 2 patient groups

Tenofovir + emtricitabine + lopinavir/r

Active Comparator group

Description:

Standard postexposure prophylaxis combination

Treatment:

Drug: Tenofovir, Emtricitabine, Lopinavir/r

Tenofovir + Emtricitabine + Raltegravir

Experimental group

Description:

new postexposure prophylaxis combination

Treatment:

Drug: Tenofovir, Emtricitabine, Raltegravir