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

NCT01348282 | Completed Phase 4

• 1 other identifier: TRIANT-TE
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Neurocognitive Disturbance; HIV Infection

Keywords

Neurocognitive Impairment; Controlled Randomized Trial; Coadjunctive Treatments; Lithium; Rivastigmine; Antiretroviral Therapy; HIV Infection

Outcome Measures

Primary Outcomes (1)

• Percentage of persons with neurocognitive impairment in the different study groups

  The main variable to consider is the existence of HIV-associated neurocognitive impairment. Therefore, the percentage of persons with neurocognitive impairment in different study groups will be the main variable that will report on the improvement associated with new treatments.

  From screening to month 12

Secondary Outcomes (5)

• Adverse events associated with the initiation of therapy and toxicity parameters

  Week 2, month 1, 3, 6, 9, 12

• Emotional variables

  Baseline, month 3, 6, 12.

• Functional variables

  Baseline, month 3, 6, 12.

• Quality of life variables

  Baseline, month 3, 6, 12.

• Demographics

  Baseline

Study Arms (3)

Lithium

EXPERIMENTAL

Lithium group: Patients who will initiate therapy with lithium, in tablets, beginning a 2-daily 400 mg dose, and changing further adjusting the dose according to drug levels in serum.

Drug: Lithium

Rivastigmine

ACTIVE COMPARATOR

rivastigmine, in transdermal patch administration, beginning a once-daily 4.6 mg dose, and changing further increasing the dose up to once-daily 9.5 mg.

Drug: Rivastigmine

Control group

NO INTERVENTION

Patients who will not initiate treatment

Interventions

Lithium DRUG

lithium, in tablets, beginning a 2-daily 400 mg dose, and changing further adjusting the dose according to drug levels in serum.

Lithium

Rivastigmine DRUG

rivastigmine, in transdermal patch administration, beginning a once-daily 4.6 mg dose, and changing further increasing the dose up to once-daily 9.5 mg.

Rivastigmine

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia: lead

Study Sites (1)

Fundació LLuita contra la SIDA

Badalona, Barcelona, 08916, Spain

Location

MeSH Terms

Conditions

Cognition Disorders; HIV Infections

Interventions

Lithium; Rivastigmine

Condition Hierarchy (Ancestors)

Neurocognitive Disorders; Mental Disorders; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Metals, Alkali; Elements; Inorganic Chemicals; Metals, Light; Metals; Phenylcarbamates; Carbamates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2011
• First Posted: May 5, 2011
• Study Start: May 1, 2011
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: April 1, 2014

Record last verified: 2014-03

Locations

ES (1)