A clinical trial to compare brain function and neurocognitive performance in antiretroviral treatments with different levels of penetration in the central nervous system.

• Conditions: Patients infected with human immunodeficiency virus who have never received antiretroviral treatment.; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2012-003595-39-ES
• Lead Sponsor: Fundación para la Investigación Biomédica del Hospital Universitario La Paz

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-11-29
• Last Update Posted: 18 February 2013

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

- HIV-positive by ELISA and confirmed by WB
- Age> 18 years
- Never have received antiretroviral treatment for HIV
- CV baseline of HIV> 100,000 copies / mL
- No evidence of genotypic resistance against antiretroviral
- Study HLA B5701 negative
- Having a VL <100,000 copies / mL
- Able to understand and give written informed consent.
- Meet the criteria to initiate the AR treatment according to Gesida 2012 Guideline.
-Women of childbearing potential should have a pregnancy test negative in blood or urine during the 7 days prior to initiation of therapy and postmenopausal women should have amenorrhea for at least 12 months to consider that they are of childbearing age.
- Non pregnant or lactating without heterosexual activity during the entire study or heterosexual activity and willing to use two methosds of contraception. The two methods of contraception can be 2 barrier methods or a barrier method and a method to prevent pregnancy hormone, used during the entire study and for 12 weeks after completion.
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 40
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Pregnant or lactating women and women of childbearing age who are not committed to use adequate contraception method.
2. Previous history of serious confounding neurological comorbidities defined as:
- Dependence on drugs or alcohol
- CNS opportunistic infections
- Major depression or psychosis
- Previous diagnosis of dementia
- Mental retardation
- CNS neurological disease
- Co-infection with hepatitis C virus
3. Claustrophobia
4. Existence of magnetizable body devices
5. Inability to perform and complete a full neurologic assessment
6. Renal insufficiency (creatinine clearance <60 mL / min)
7. Diabetes mellitus or cardiovascular risk> 10% calculated by Framingham
8. The following analytical criteria:
- Neutropenia <750 cells / ?L
- Hemoglobin <8.0 g / dL
- Platelets <50,000 cells / ?L
- Levels of GOT, GPT and GGT greater than 5 times the baseline levels

Study & Design

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