Short-term Disulfiram Administration to Reverse Latent HIV Infection: a Dose Escalation Study

Exclusion Criteria

• •Current alcohol use disorder or hazardous alcohol use
• •Current use of any drug formulation that contains alcohol or that might contain alcohol, including the gelatin capsule and liquid formulations of ritonavir, ritonavir/lopinavir, amprenavir and fosamprenavir.
• •Current use of tipranavir or maraviroc.
• •Current use of zidovudine, stavudine or didanosine (as disulfiram potentially has potent irreversible inhibitory effects on mitochondrial metabolism and hence could exacerbate the toxicity of these drugs).
• •Concurrent use of rivaroxaban ( a CYP3A metabolized medication) as the cytochrome P450 inhibitory effects of disulfiram on rivaroxaban are unknown.
• •Current use of warfarin
• •Patients who are intending to modify antiretroviral therapy in the next 2 weeks for any reason.
• •Serious illness requiring hospitalization or parental antibiotics within preceding 3 months
• •A screening hemoglobin below 12.5 g/dL
• •A screening TSH consistent with Hypothyroidism
• •Significant renal disease or acute nephritis
• •Significant myocardial disease or diagnosed coronary artery disease
• •Significant respiratory disease
• •History of psychosis, seizure disorder, abnormal electroencephalogram or brain damage with significant persisting neurological deficit.
• •Clinically active hepatitis as evidenced by clinical jaundice or Grade 2 or higher liver function test abnormalities.
• •Hepatic cirrhosis or decompensated chronic liver disease.
• •Diabetes or current hypothyroidism.
• •Concurrent treatment with immunomodulatory drugs, or exposure to any immunomodulatory drug in past 16 weeks.
• •Recent exposure (within the preceding 8 weeks) to any vaccine.
• •Pregnant or breastfeeding women. Women of childbearing potential must have a negative serum pregnancy test at screening and agree to use a double-barrier method of contraception throughout the study period.
• •Significant substance use, which in the opinion of the investigator, is likely to interfere with the conduct of the study.
• •Prior or current use of disulfiram, vorinostat or other experimental agent used with the intent to perturb the HIV-1 viral reservoir
• •Current use of an antiretroviral regimen which does not include either efavirenz or a protease inhibitor