Human Immunodeficiency Virus (HIV) Infections and Infestations Human Immunodeficiency Virus (HIV)
Conditions
Interventions
Selenium supplement (200 ug/day) versus placebo
Sponsors
National Institute on Drug Abuse (USA)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Participants provided informed consent 2. Presented documented evidence of their HIV-1 infection 3. Were 18 to 55 years of age 4. Were not being treated pharmacologically for a diagnosed cardiovascular condition (e.g., beta-blockers, calcium antagonists, Angiotensin-Converting Enzyme [ACE] inhibitors), for carbohydrate conditions (e.g., hypoglycemics, insulin sensitizers), for psychiatric conditions (e.g., antipsychotics, antidepressives), and for endocrine conditions (e.g., estrogen hormonal replacement) 5. Presented no evidence of myocardial infarction or Atrio-Ventricular (AV) conduction arrhythmias upon electrocardiogram 6. Had no history of diabetes or cardiovascular disorder, or other major systemic diagnosis unrelated to HIV spectrum disease 7. Had no gross neurocognitive dysfunction indicated by a Folstein Mini-Mental Status Exam (MMSE) score 50 ug per pill 12. Had a serum selenium level upon screen equal or superior to 75 ug/l. Participants meeting these criteria signed an informed consent form for screening and if still eligible additional written consent was obtained for randomization into the trial.
Exclusion criteria
Exclusion criteria: 1. Participating in another blinded clinical trial 2. Being treated pharmacologically (e.g., beta-blockers, calcium antagonists, ace inhibitors) for diagnosed cardiovascular function 3. Pregnant or have the intent to become pregnant 4. Post-menopausal women 5. Presenting an electrocardiogram (ECG) arrhythmia in which the proposed cardiovascular assessments would be contraindicated 6. Taking any medications that have contraindicating cardiovascular effects (i.e., tricyclic anti-depressant medications, etc.) 7. Displaying gross neurocognitive dysfunction indicated by a Folstein Mini-Mental Status Exam (MMSE) score equal or superior to 26
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HIV viral load, CD4 count, metabolic syndrome, cardiac contractility, cardiac compliance, cardiac mass | — |
Secondary
| Measure | Time frame |
|---|---|
| Oxidative stress, inflammation | — |
Countries
United States of America
Outcome results
None listed