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)
|ClinicalTrials.gov Identifier: NCT01576731|
Recruitment Status : Completed
First Posted : April 12, 2012
Last Update Posted : April 1, 2015
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 or disease||Intervention/treatment||Phase|
|HIV Infection||Drug: Tenofovir, Emtricitabine, Lopinavir/r Drug: Tenofovir, Emtricitabine, Raltegravir||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||240 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||July 2012|
|Actual Primary Completion Date :||July 2014|
|Actual Study Completion Date :||July 2014|
Active Comparator: Tenofovir + emtricitabine + lopinavir/r
Standard postexposure prophylaxis combination
Drug: Tenofovir, Emtricitabine, Lopinavir/r
Experimental: Tenofovir + Emtricitabine + Raltegravir
new postexposure prophylaxis combination
Drug: Tenofovir, Emtricitabine, Raltegravir
- Proportion of patients dropping out before the 28 days of postexposure prophylaxis [ Time Frame: 28 days ]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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01576731
|Hospital Clínic of Barcelona|
|Barcelona, Spain, 08036|
|Principal Investigator:||Felipe Garcia, PhD||Consultant senior|