Efficacy and Safety of Two Pharmacologic Strategies on Neurocognitive Impairment in HIV Infection. The TRIANT-TE Study

• Status: Completed
• Trial end date: 2014-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The current project proposes the comparison of two pharmacologic strategies as adjunctive treatments for the improvement of HIV-associated neurocognitive disruption, additionally to use of HAART. The investigators propose the use of the compound that has shown greatest benefits in this context to date, the lithium, versus the use of a well-tolerated and promising drug in other pathologies with neurocognitive affectation, such as Alzheimer or Parkinson diseases, which is the rivastigmine. In those other diseases, this second compound has recently offered a good tolerability, but also benefits on attention, memory and other neurocognitive areas. Both study groups, patients on therapy with lithium and patients on therapy with rivastigmine, will be compared to a control group, which will not initiate any other treatment (therefore only continuing antiretroviral therapy). The investigators are aware that this proposal will offer new relevant data for the study of neurocognitive improvement in HIV infection, as well will allow a better knowledge of clinical management of HIV-infected patients with CNS disease, an aspect that is a common clinical concern today.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fundacio Lluita Contra la SIDA; Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
• Treatments: Lithium Carbonate; Rivastigmine

Criteria

Inclusion Criteria:

• Age ranged from 20 to 75 years old

• Correct understanding of study objectives

• Written consent signed

• HIV infection confirmed by Western Blot or two ELISA tests

• Existence of an HIV-associated neurocognitive disorder according to the diagnosis classification offered by Antinori and cols (Neurology, 2007)

• Being on antiretroviral treatment.

• Spanish/Catalan speaker.

Exclusion Criteria:

• To be on a treatment that may interact pharmacologically with any of the new drugs used in study arms.

• Breastfeeding, pregnancy or fertile women willing to be pregnant.

• Renal failure or severe cardiovascular disease.

• Weakness, dehydration or severe sodium depletion.

• Sick sinus syndrome or cardiac conduction disturbances (sinoatrial block or atrioventricular block).

• Active duodenal or gastric ulcer.

• Urinary obstruction.

• Epilepsy.

• Chronic obstructive pulmonary disease (COPD).