Outcome of plasma lipid profile in patients switching from Atripla® to Eviplera® compared to continuing on Atripla® (EfaRiLipidomics)

Phase 1

• Conditions: HIV-1 Infection; MedDRA version: 18.0Level: PTClassification code 10020161Term: HIV infectionSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2015-002319-13-ES
• Lead Sponsor: Fundació Hospital Vall Hebron Institut de Recerca

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-07-10
• Last Update Posted: 3 April 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

- Patients aged 18 years or above
- Patients infected with HIV-1
- Patients in treatment with Atripla for at least the last six months.
- Patients with virologic suppression ( RNA -HIV <50 copies / ml ) for at least the last six months .
- Fertile Women must use a double barrier contraceptive method
- Voluntary signature of the informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 28
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 2

Exclusion Criteria

- Any acute or chronic disease (besides the chronic infection for HIV 1) that could interfere in the lipidomic analysis
- Pregnant or nursing women
- Abuse of alcohol or other drugs
- BMI > 25
- Use of drugs that may affect lipid metabolism ( lipid lowering drugs , steroids ... )
- Patients unable to understand the protocol of the study or any other condition that in opinion of the investigator could compromise the fulfillment of the protocol
- History or presence of allergy to any of the study drugs or their components

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified