Study Comparing Two Alternatives of Antiretroviral Therapy as Post-exposure Prophylaxis to HIV-1:FOVIR+EMTRICITABINA + LOPINAVIR/RITONAVIR VS TENOFOVIR+EMTRICITABINA + MARAVIROC (MARAVI-PEP)

Hospital Clinic of Barcelona

Status and phase: Completed; Phase 4

Conditions: HIV Infection

Treatments: Drug: Tenofovir, emtricitabine, maraviroc; Drug: Tenofovir, emtricitabine, lopinavir/r

Study type: Interventional

Funder types: Other

Identifiers

NCT01533272

MARAVI-PEP

Details and patient eligibility

About

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.

Enrollment: 240 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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240 participants in 2 patient groups

Tenofovir, emtricitabine, Maraviroc

Experimental group

Description:

New postexposure prophylaxis (it is a combination drug)

Treatment:

Drug: Tenofovir, emtricitabine, maraviroc

Tenofovir, emtricitabine, lopinavir/r

Active Comparator group

Description:

Standard prophylaxis (it is a combination drug)

Treatment:

Drug: Tenofovir, emtricitabine, lopinavir/r