Study Comparing Two Alternatives of Antiretroviral Therapy as Post-exposure Prophylaxis to HIV-1:FOVIR+EMTRICITABINA + LOPINAVIR/RITONAVIR VS TENOFOVIR+EMTRICITABINA + MARAVIROC (MARAVI-PEP)
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.
|HIV Infection||Drug: Tenofovir, emtricitabine, maraviroc Drug: Tenofovir, emtricitabine, lopinavir/r||Phase 4|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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|
- Proportion of patients reaching 28 days of postexposure prophylaxis. [ Time Frame: 28 days ]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
|Study Start Date:||February 2012|
|Study Completion Date:||June 2014|
|Primary Completion Date:||June 2014 (Final data collection date for primary outcome measure)|
Experimental: Tenofovir, emtricitabine, Maraviroc
New postexposure prophylaxis (it is a combination drug)
Drug: Tenofovir, emtricitabine, maraviroc
Active Comparator: Tenofovir, emtricitabine, lopinavir/r
Standard prophylaxis (it is a combination drug)
Drug: Tenofovir, emtricitabine, lopinavir/r
Lopinavir/r 400mg BID
Please refer to this study by its ClinicalTrials.gov identifier: NCT01533272
|Hospital Clinic de Barcelona|
|Barcelona, Spain, 08036|
|Principal Investigator:||Felipe Garcia, PhD||Consultant|