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. (see Contacts and Locations)

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

History of Changes

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:

MedlinePlus related topics: HIV/AIDS

Drug Information available for: Emtricitabine Tenofovir Lopinavir Tenofovir Disoproxil Fumarate Raltegravir Raltegravir potassium

U.S. FDA Resources

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

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

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

ClinicalTrials.gov processed this record on February 27, 2015

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