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Study Comparing Two Alternatives of Antiretroviral Therapy as Post-exposure Prophylaxis to HIV-1:FOVIR+EMTRICITABINA + LOPINAVIR/RITONAVIR VS TENOFOVIR+EMTRICITABINA + MARAVIROC (MARAVI-PEP)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Felipe Garcia, Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier:
NCT01533272
First received: February 8, 2012
Last updated: March 31, 2015
Last verified: March 2015
  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 10-35% interruption of PEP Maraviroc, a CCR5 receptor antagonist, very well tolerated, coul be an adequate drug for PEP.


Condition Intervention Phase
HIV Infection
Drug: Tenofovir, emtricitabine, maraviroc
Drug: Tenofovir, emtricitabine, lopinavir/r
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+EMTRICITABINA + LOPINAVIR/RITONAVIR VS TENOFOVIR+EMTRICITABINA + MARAVIROC

Resource links provided by NLM:


Further study details as provided by Hospital Clinic of Barcelona:

Primary Outcome Measures:
  • Proportion of patients reaching 28 days of postexposure prophylaxis. [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
    Postexposure prophylaxis has to be used during 28 days to have effectiveness. It is thought that a shorter period of treatment does not prevent HIV infection according to animal models. Therefore, we will assess the proportion of patients who complete the total period of treatment in each arm of the study. The hypothesis is that a higher proportion of patients who take the medication with lower side effects will complete the 28 days of postexposure prophylaxis


Enrollment: 240
Study Start Date: February 2012
Study Completion Date: June 2014
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Tenofovir, emtricitabine, Maraviroc
New postexposure prophylaxis (it is a combination drug)
Drug: Tenofovir, emtricitabine, maraviroc
experimental drug
Active Comparator: Tenofovir, emtricitabine, lopinavir/r
Standard prophylaxis (it is a combination drug)
Drug: Tenofovir, emtricitabine, lopinavir/r
Lopinavir/r 400mg BID

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Both sexes
  • Older than 18 years old
  • A potentially sexual exposition to HIV
  • Accept to participate

Exclusion Criteria:

  • Pregnant women
  • The source case a person with HIV antiretroviral resistances
  • Persons with a treatment that is contraindicated with the drugs in the 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: NCT01533272

Locations
Spain
Hospital Clinic de Barcelona
Barcelona, Spain, 08036
Sponsors and Collaborators
Hospital Clinic of Barcelona
Investigators
Principal Investigator: Felipe Garcia, PhD Consultant
  More Information

Responsible Party: Felipe Garcia, PhD, Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier: NCT01533272     History of Changes
Other Study ID Numbers: MARAVI-PEP 
Study First Received: February 8, 2012
Last Updated: March 31, 2015
Health Authority: Spain: Ministry of Health and Consumption

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
Emtricitabine
Maraviroc
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
CCR5 Receptor Antagonists

ClinicalTrials.gov processed this record on December 08, 2016