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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

April 3, 2012
March 18, 2014
July 2012
July 2014   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01576731 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Study Comparing Two Alternatives of Antiretroviral Therapy as Post-exposure Prophylaxis to HIV-1: Tenofovir + Emtricitabine + Lopinavir/Ritonavir Versus Tenofovir + Emtricitabine + Raltegravir (RAL-PEP)
Open Randomized Study Comparing Two Alternatives of Antiretroviral Therapy as Post-exposure Prophylaxis to HIV-1: Tenofovir + Emtricitabine + Lopinavir/Ritonavir Versus Tenofovir + Emtricitabine + Raltegravir

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.

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, Lopinavir/r
    Combination drug
  • Drug: Tenofovir, Emtricitabine, Raltegravir
    Combination drug
  • Active Comparator: Tenofovir + emtricitabine + lopinavir/r
    Standard postexposure prophylaxis combination
    Intervention: Drug: Tenofovir, Emtricitabine, Lopinavir/r
  • Experimental: Tenofovir + Emtricitabine + Raltegravir
    new postexposure prophylaxis combination
    Intervention: Drug: Tenofovir, Emtricitabine, Raltegravir
Not Provided

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

Inclusion Criteria:

  • Potentially sexual exposition to HIV

Exclusion Criteria:

  • Pregnancy
  • Source case with antiretroviral resistances
  • any treatment contraindicated with the drugs of study
Both
18 Years and older
Yes
Contact: García NA Felipe, MD +34932275400 ext 2884 fgarcia@clinic.ub.es
Spain
 
NCT01576731
2011-003799-35
No
Felipe Garcia, Hospital Clinic of Barcelona
Hospital Clinic of Barcelona
Not Provided
Principal Investigator: Felipe Garcia, PhD Consultant senior
Hospital Clinic of Barcelona
March 2014

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