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Clinical Trials

MainTitle

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

This study has been completed
Sponsor
Hospital Clinic of Barcelona


Information provided by (Responsible Party)
Felipe Garcia, Hospital Clinic of Barcelona

ClinicalTrials.gov Identifier
NCT01576731

First received: April 3, 2012
Last updated: March 31, 2015
Last Verified: March 2015
History of Changes
Purpose

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
Intervention Model: Parallel Assignment
Masking: None (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

Further study details as provided by Felipe Garcia, Hospital Clinic of Barcelona:

Primary Outcome Measures

  • Proportion of patients dropping out before the 28 days of postexposure prophylaxis [ Time Frame: 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

Enrollment: 240
Study Start Date: July 2012
Study Completion Date: July 2014
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

Eligibility

Ages Eligible for Study: 18 Years and older  
Sexes Eligible for Study: All  
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

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01576731

Locations

Spain
Hospital Clínic of Barcelona
Barcelona, Spain, 08036

Sponsors and Collaborators

Hospital Clinic of Barcelona

Investigators

Principal Investigator: Felipe Garcia, PhD Consultant senior
More Information

More Information


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 31, 2015  

Keywords provided by Felipe Garcia, Hospital Clinic of Barcelona:

HIV Infection
Postexposure prophylaxis

Additional relevant MeSH terms:
HIV Infections
Ritonavir
Lopinavir
Tenofovir
Raltegravir Potassium
Emtricitabine

ClinicalTrials.gov processed this data on October 19, 2017
This information is provided by ClinicalTrials.gov.