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

NCT01576731 | Completed Phase 4

• 1 other identifier: 2011-003799-35
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV Infection

Keywords

HIV Infection; Postexposure prophylaxis

Outcome Measures

Primary Outcomes (1)

• 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

  28 days

Study Arms (2)

Tenofovir + emtricitabine + lopinavir/r

ACTIVE COMPARATOR

Standard postexposure prophylaxis combination

Drug: Tenofovir, Emtricitabine, Lopinavir/r

Tenofovir + Emtricitabine + Raltegravir

EXPERIMENTAL

new postexposure prophylaxis combination

Drug: Tenofovir, Emtricitabine, Raltegravir

Interventions

Tenofovir, Emtricitabine, Lopinavir/r DRUG

Combination drug

Tenofovir + emtricitabine + lopinavir/r

Tenofovir, Emtricitabine, Raltegravir DRUG

Combination drug

Tenofovir + Emtricitabine + Raltegravir

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Potentially sexual exposition to HIV

You may not qualify if:

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

Sponsors & Collaborators

• Hospital Clinic of Barcelona: lead

Study Sites (1)

Hospital Clínic of Barcelona

Barcelona, Barcelona, 08036, Spain

Location

Related Publications (1)

• 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.

  PMID: 26994089 DERIVED

MeSH Terms

Conditions

HIV Infections

Interventions

Tenofovir; Emtricitabine; Raltegravir Potassium

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Pyrrolidinones; Pyrrolidines

Study Officials

• Felipe Garcia, PhD

  Consultant senior

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: April 3, 2012
• First Posted: April 12, 2012
• Study Start: July 1, 2012
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: April 1, 2015

Record last verified: 2015-03

Locations

ES (1)