Comparison between a Raltegravir-based treatment versus a raltegravir-based treatment plus atorvastatin for reducing aging-related inflamation in HIV-infected patients older than 60 years.

Phase 1

Conditions: aging-related inflamation in HIV-infected patients
MedDRA version: 18.0Level: LLTClassification code 10020175Term: HIV infection with other conditionsSystem Organ Class: 100000004862
MedDRA version: 18.0Level: LLTClassification code 10008919Term: Chronic HIV infectionSystem Organ Class: 100000004862
Therapeutic area: Diseases [C] - Virus Diseases [C02]

Registration Number: EUCTR2015-002682-30-ES

Lead Sponsor: Fundació Lluita contra la SIDA

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 60

Inclusion Criteria

1. Patient having a diagnosis of HIV-1 infection.
2. Age higher or equal to 60 years old.
3. Current HAART including Truvadaâ or Kivexaâ plus a ritonavir boosted PI started at least 6 months before.
4. Maintained undetectable plasma HIV-1 RNA (VL < 50 copies/mL) for at least 12 months.
5. Voluntary written informed consent.
6. In women of childbearing age, commitment to use barrier contraceptive method throughout the study.
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 60
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 60

Exclusion Criteria

1. History of virological failure to integrase inhibitors.
2. Suspected or documented resistance mutations to the integrase, as well as NRTI?related mutations that may impact nucleoside activity in current regimen.
3. Systemic concurrent process such as coinfection with hepatitis C or B, acute systemic infection within the last 4 months, neoplasm, chronic inflammatory process, etc.
4. Treatment with other drugs with anti-inflammatory, anticoagulant or antiplatelet effect (for instance corticosteroids, aspirin, etc?)
5. Therapy with statins within the last 6 months.
6. Pregnant or lactating women.