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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 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:
NCT01533272
First received: February 8, 2012
Last updated: March 18, 2014
Last verified: March 2014

February 8, 2012
March 18, 2014
February 2012
June 2014   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01533272 on ClinicalTrials.gov Archive Site
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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)
Open Randomized Study Comparing Two Alternatives of Antiretroviral Therapy as Post-exposure Prophylaxis to HIV-1: TENOFOVIR+EMTRICITABINA + LOPINAVIR/RITONAVIR VS TENOFOVIR+EMTRICITABINA + MARAVIROC

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
HIV Infection
  • Drug: Tenofovir, emtricitabine, maraviroc
    experimental drug
  • Drug: Tenofovir, emtricitabine, lopinavir/r
    Lopinavir/r 400mg BID
  • Experimental: Tenofovir, emtricitabine, Maraviroc
    New postexposure prophylaxis (it is a combination drug)
    Intervention: Drug: Tenofovir, emtricitabine, maraviroc
  • Active Comparator: Tenofovir, emtricitabine, lopinavir/r
    Standard prophylaxis (it is a combination drug)
    Intervention: Drug: Tenofovir, emtricitabine, lopinavir/r
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
240
June 2014
June 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
Yes
Contact: Felipe García, MD 0034932275400 ext 2884 fgarcia@clinic.ub.es
Spain
 
NCT01533272
MARAVI-PEP
Yes
Felipe Garcia, Hospital Clinic of Barcelona
Hospital Clinic of Barcelona
Not Provided
Principal Investigator: Felipe Garcia, PhD Consultant
Hospital Clinic of Barcelona
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP