CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 63 enrolled
Drug / intervention
Galantamine +1 moredrug
Likely dose
Galantamine 8mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03384784
NCT03384784Phase 2Completed
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Targeting the Cholinergic Pathway in HIV-associated Inflammation and Cognitive Dysfunction

University of Pennsylvania·interventional·Posted Dec 27, 2017·Updated Oct 17, 2024

In Brief

A Phase 2 clinical trial evaluating Galantamine and Placebo for HIV Associated Cognitive Motor Complex. Completed, enrolled 63 participants across 1 site.

Detailed Summary

This study tests whether galantamine (GAL) reduces HIV-related inflammation and cognitive deficits. In this double-blind placebo-controlled crossover study, HIV-infected individuals (N=120; 60 smokers and 60 non-smokers) will be randomized to 12 weeks of GAL or placebo, followed by a 4-week washout, then 12 weeks of GAL or placebo (arms switched). Outcomes are monocyte/macrophage and T cell activation and neurocognitive performance.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV Associated Cognitive Motor Complex
CountriesUnited States
CollaboratorsNational Institute on Drug Abuse (NIDA)

Timeline

Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedDec 27, 2017
Enrollment StartOct 30, 2017
Primary CompletionMay 31, 2022
TodayJul 2, 2026
Enrollment to primary: 4.6 yearsPosted 8.5 years ago

Interventions

Galantaminedrug

The study will be performed using the 8mg, 16mg and 24mg doses of galantamine hydrobromide-ER. The dosing regimen will be an initial 4 weeks of drug run-up at the lowest 8mg q.d. dose, followed by 16mg q.d. for the following 4 weeks, and the dose will be increased for the last 4 weeks to 24mg. Participants will be instructed to take one 8mg 16mg or 24mg pill (galantamine-ER or placebo) every morning, preferably with food.

Placebodrug

Matched placebo will be made in-house using lactulose filler in gel capsules. Participants will be instructed to take one pills every morning for 12 weeks.