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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01533272

Enrollment

240

Registered

2012-02-15

Start date

2012-02-29

Completion date

2014-06-30

Last updated

2015-04-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infection

Keywords

HIV infection, Postexposure prophylaxis

Brief summary

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.

Interventions

DRUGTenofovir, emtricitabine, maraviroc

experimental drug

DRUGTenofovir, emtricitabine, lopinavir/r

Lopinavir/r 400mg BID

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Proportion of patients reaching 28 days of postexposure prophylaxis.	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

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 2, 2026