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:

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

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 Ritonavir 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


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


Ages Eligible for Study:	18 Years and older (Adult, Senior)
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

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


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
Health Authority:	Spain: Spanish Agency of Medicines

Keywords provided by Hospital Clinic of Barcelona:


HIV Infection Postexposure prophylaxis

Additional relevant MeSH terms:


HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Ritonavir Lopinavir Tenofovir Raltegravir Potassium Emtricitabine	HIV Protease Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Cytochrome P-450 CYP3A Inhibitors Cytochrome P-450 Enzyme Inhibitors Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors HIV Integrase Inhibitors Integrase Inhibitors

ClinicalTrials.gov processed this record on September 29, 2016

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