Study Comparing Two Alternatives of Antiretroviral Therapy as Post-exposure Prophylaxis to HIV-1:FOVIR+EMTRICITABINA + LOPINAVIR/RITONAVIR VS TENOFOVIR+EMTRICITABINA + MARAVIROC (MARAVI-PEP)
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|ClinicalTrials.gov Identifier: NCT01533272|
Recruitment Status : Completed
First Posted : February 15, 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 10-35% interruption of PEP Maraviroc, a CCR5 receptor antagonist, very well tolerated, coul be an adequate drug for PEP.
|Condition or disease||Intervention/treatment||Phase|
|HIV Infection||Drug: Tenofovir, emtricitabine, maraviroc Drug: Tenofovir, emtricitabine, lopinavir/r||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+EMTRICITABINA + LOPINAVIR/RITONAVIR VS TENOFOVIR+EMTRICITABINA + MARAVIROC|
|Study Start Date :||February 2012|
|Actual Primary Completion Date :||June 2014|
|Actual Study Completion Date :||June 2014|
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
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01533272
|Hospital Clinic de Barcelona|
|Barcelona, Spain, 08036|
|Principal Investigator:||Felipe Garcia, PhD||Consultant|