Galantamine Hydrobromide in Reducing Inflammation and Thinking Problems in Patients with HIV-1

Inclusion Criteria

• Diagnosed with HIV-1 infection
• On stable antiretroviral therapy (ART) regimens (no changes to treatment within 4 weeks of intake visit)
• Viral load of less than or equal to 200 copies/mL
• Current CD4 counts greater than 200
• If current or past diagnosis of bipolar disorder, eligible if: * No psychotic features * Montgomery-Asberg depression rating scale (MADRS): total score less than 8 (past 4 weeks), suicidal item score less than 1 (past 4 weeks) * Young mania rating scale (Y-MRS): total score less than 8 (past 4 weeks), irritability, speech content, disruptive or aggressive behavior items score less than 3 (past 4 weeks) * No psychiatric hospitalization or emergency room visits for psychiatric issues in the past 6 months * No aggressive or violent acts or behavior in the past 6 months
• Able to communicate in English and provide written informed consent
• Will be residing in the geographic area for at least 7 months
• Not currently trying to quit smoking
• Smoking Status * Smokers (HIV+ S) will report smoking at least 5 cigarettes per day, on average for the past year and provide a breath carbon monoxide (CO) sample greater than 5 ppm at intake and at the beginning of each treatment period * Non-smokers (HIV+ NS) will report smoking fewer than 100 cigarettes in their lifetime, or, less than 5 pack years of smoking and no cigarettes smoked in the last year. They will self-report no current use of any tobacco or nicotine product and will provide a CO sample of less than 3 ppm at intake and at the beginning of each treatment period

Exclusion Criteria

• Current enrollment or plans to enroll in another smoking cessation program in the next 7 months
• Regular (daily) use of electronic cigarettes, chewing tobacco, snuff, snus, cigars, cigarillos, or pipes
• Current use or plans to use nicotine substitutes (gum, patch, lozenge, e-cigarette) or smoking cessation treatments in the next 7 months
• Current untreated and unstable diagnosis of substance abuse or dependence (if past use and if receiving treatment and stable for at least 30 days, eligible)
• Breath alcohol concentration (BrAC) greater than 0.00 at Intake visit or beginning of either treatment period
• Positive urine drug screen for cocaine, methamphetamines, phencyclidine (PCP), barbiturates, ecstasy (3,4-methylenedioxymethamphetamine [MDMA]), at intake or beginning of each treatment period. Those who screen positive for amphetamines, benzodiazepines, methadone, oxycodone, and/or opiates (low level cut-off 300 ng/mL) and who are prescribed these medications will be reviewed on a case-by-case basis by the study physician and principal investigators (PIs)
• Women who are pregnant, planning a pregnancy or lactating
• Current diagnosis of unstable and untreated major depression (if stable for at least 30 days, eligible)
• Current or past diagnosis of psychotic disorder
• A history or current diagnosis of cancer
• Major heart disease or stroke within the past 6 months
• Uncontrolled hypertension (systolic blood pressure [SBP] greater than 160 or diastolic blood pressure [DBP] greater than 100)
• Medical conditions contraindicated for use with galantamine: * Diagnosis of Alzheimer’s disease or dementia * Epilepsy or other seizure disorder
• Active hepatitis C virus (HCV) co-infection (if cured, requires study physician approval)
• Liver function tests more than 20% outside of the normal range; gamma-glutamyl transpeptidase (GGT) values more than 20% outside of the normal range. If albumin/globulin ratios are 20% outside of normal range the abnormal value will be evaluated for clinical significance by the study physician and eligibility will be determined on a case-by-case basis
• Renal disease or renal dysfunction (e.g., serum creatinine levels greater than 1.5 x upper limit of normal). Those with moderate hepatic impairment or creatinine clearance 9 to 59 mL/min shall not exceed the 16 mg/day dose.
• Suicide risk as measured by the Columbia Suicide Severity Rating Scale
• Current use or discontinuation within the last 14 days of: * Quit smoking medications including varenicline (Chantix), bupropion (Wellbutrin) * Anti-psychotic medications (e.g., Zyprexa, Clozaril, Seroquel, Risperdal). If used to treat psychotic symptoms. Other uses may be eligible pending physician approval * Systemic steroids (e.g., Prednisone) * Alzheimer's disease medications (e.g., acetylcholinesterase inhibitors (ACIs), Aricept/donepezil, Exelon/rivastigmine, Tacrine, or memantine) * Irritable bowel syndrome medication (e.g., Dicyclomine/Bentyl) * Heart medications (e.g., quinidine) * Muscle relaxants (e.g., Anectine/succinylcholine) * Urinary retention medications (e.g., Duvoid/bethanechol, Proscar/finasteride, Avodart/dutasteride, Dibenzyline/ phenoxybenzamine, Regitine/phentolamine) * Eye medication (e.g., Atropine)
• Daily use of: * Opiate-containing medications for chronic pain (Duragesic/fentanyl patches, Percocet, Oxycontin). Smokers who report taking opiate-containing medications on an “as-needed” basis will be instructed to refrain from use until their study participation is over and that they will be tested to ensure they have complied with this requirement * Chronic obstructive pulmonary disease (COPD) medication (e.g., Atrovent/Ipratropium Bromide)
• Known allergy to study medication. * Subjects will be instructed to refrain from using any study prohibited drugs/medications (both recreational and prescription) throughout their participation in the study