Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:06 PM
Ignite Modification Date:
2025-12-24 @ 3:06 PM
NCT ID:
NCT01286259
Eligibility Criteria:
Inclusion Criteria:
* Documented continuous HAART for at least 18 months prior to study entry and on a stable regimen for at least 3 months prior to entry.
* Documented undetectable HIV viral loads for at least one year. Intermittent isolated episodes of detectable low-level viremia "blips" (\> 50 but \< 500 copies RNA/mL) remain eligible.
* Screening plasma HIV-1 RNA levels \< 40 copies RNA/mL.
* CD4 T-cell count above 200 cells/uL for 24 weeks prior to screen.
* \>90% adherence to therapy within the preceding 30 days.
* Females 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.
* Willing to abstain from any alcohol during the two week period in which disulfiram will be administered and during the two week period immediately after disulfiram administration.
Exclusion Criteria:
* Current alcohol use disorder or hazardous alcohol use as determined by clinical evaluation.
* Current use of any drug formulation that contains alcohol or that might contain alcohol.
* Current use of tipranavir.
* Current use of maraviroc.
* Current use of warfarin.
* Intending to modify antiretroviral therapy in the next 27 weeks for any reason.
* Serious illness requiring hospitalization or parental antibiotics within preceding 3 months.
* Severe myocardial disease or coronary artery disease.
* History of psychosis.
* Clinically active hepatitis determined by the study physician; ALT or AST \>3 x the upper limit of normal.
* Concurrent treatment with immunomodulatory drugs, or exposure to any immunomodulatory drug in past 16 weeks.
* Pregnant or breastfeeding women.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01286259
Study Brief:
Protocol Section:
NCT01286259