Evolution of Plasma Lipid Profile in Patients With HIV1 Who Change Atripla to Eviplera Compared to Continue With Atripla

Vall d'Hebron University Hospital (HUVH)

Status and phase: Completed; Phase 4

Conditions: HIV-1

Treatments: Drug: rilpivirina + emtricitabina + tenofovir; Drug: efavirenz + emtricitabina + tenofovir

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02547844

EfaRiLipidomics

Details and patient eligibility

About

To compare the lipidomic profile in patients with HIV-1 with viral suppression changing efavirenz + emtricitabine + tenofovir (Atripla) to rilpivirine + emtricitabine + tenofovir (Eviplera®) versus a group of patients that continue with Atripla®.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients aged 18 years or above
• Patients infected with HIV-1
• Patients treated with Atripla at least the last 6 months.
• Patients with virologic suppression (HIV RNA <50 copies / ml) for at least the last 6 months.
• Women of childbearing potential must use contraception double barrier.
• Voluntary signature of informed consent

Exclusion criteria

• Any acute or chronic (besides chronic HIV-1) disease that could interfere with the analysis of lipidomic
• Women pregnant or lactating
• Abuse of alcohol or other drugs
• Body Mass Index (BMI)> 25
• Use of drugs that may affect lipid metabolism (lipid-lowering drugs, steroids ...)
• Patients unable to understand the study protocol or any other condition that in the investigator's opinion could jeopardize compliance with the protocol
• History or presence of allergy to any of the study drugs or their components

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

efavirenz + emtricitabina + tenofovir

Active Comparator group

Description:

Patients assigned to the control group will continue receiving the same medication than before to be included in the study: Atripla (efavirenz + emtricitabina + tenofovir)

Treatment:

Drug: efavirenz + emtricitabina + tenofovir

rilpivirina + emtricitabina + tenofovir

Experimental group

Description:

Patients assigned to the experimental group will change the medication that are taking before to enter in the study ( atripla) for eviplera (rilpivirina + emtricitabina + tenofovir)

Treatment:

Drug: rilpivirina + emtricitabina + tenofovir