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

This study is currently recruiting participants.
Verified March 2014 by Hospital Clinic of Barcelona
Sponsor:
Information provided by (Responsible Party):
Felipe Garcia, Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier:
NCT01576731
First received: April 3, 2012
Last updated: March 18, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
HIV Infection
Drug: Tenofovir, Emtricitabine, Lopinavir/r
Drug: Tenofovir, Emtricitabine, Raltegravir
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by Hospital Clinic of Barcelona:

Primary Outcome Measures:
  • Proportion of patients dropping out before the 28 days of postexposure prophylaxis [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
    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


Estimated Enrollment: 240
Study Start Date: July 2012
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Tenofovir + emtricitabine + lopinavir/r
Standard postexposure prophylaxis combination
Drug: Tenofovir, Emtricitabine, Lopinavir/r
Combination drug
Experimental: Tenofovir + Emtricitabine + Raltegravir
new postexposure prophylaxis combination
Drug: Tenofovir, Emtricitabine, Raltegravir
Combination drug

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Potentially sexual exposition to HIV

Exclusion Criteria:

  • Pregnancy
  • Source case with antiretroviral resistances
  • any treatment contraindicated with the drugs of study
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01576731

Contacts
Contact: García NA Felipe, MD +34932275400 ext 2884 fgarcia@clinic.ub.es

Locations
Spain
Hospital Clínic of Barcelona Recruiting
Barcelona, Spain, 08036
Contact: García Felipe, MD    +34932275400 ext 2884    fgarcia@clinic.ub.es   
Principal Investigator: García Felipe, MD         
Sponsors and Collaborators
Hospital Clinic of Barcelona
Investigators
Principal Investigator: Felipe Garcia, PhD Consultant senior
  More Information

No publications provided

Responsible Party: Felipe Garcia, MD, Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier: NCT01576731     History of Changes
Other Study ID Numbers: 2011-003799-35
Study First Received: April 3, 2012
Last Updated: March 18, 2014
Health Authority: Spain: Spanish Agency of Medicines

Keywords provided by Hospital Clinic of Barcelona:
HIV Infection
Postexposure prophylaxis

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Ritonavir
Lopinavir
Tenofovir
Tenofovir disoproxil
Emtricitabine
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on April 20, 2014