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 @ 9:16 PM
Ignite Modification Date:
2025-12-24 @ 9:16 PM
NCT ID:
NCT00737204
Eligibility Criteria:
Inclusion Criteria:
1. Ages 18-75
2. HIV+
3. Clinically significant fatigue (score of 4.5+ on Fatigue Severity Scale, plus impairment on 1+ categories of Role Function Scale)
4. Fatigue duration for 3+ months
5. English-speaking
6. Able to give informed consent
7. Fecund women uses barrier method of contraception
Exclusion Criteria:
1. Primary care doctor does not approve of study participation
2. Unstable medical condition (e.g. liver failure; cirrhosis, new onset opportunistic infection in past month)
3. Untreated hypogonadism, except for men for whom testosterone replacement is medically contraindicated (serum testosterone below the reference range)
4. Untreated hypothyroidism (Thyroid Stimulating Hormone over 5 IUI/mL)
5. Untreated and uncontrolled hypertension
6. Clinically significant anemia (hematocrit \<30%)
7. Started testosterone or nandrolone in past 6 weeks
8. Started or changed an antiretroviral regimen in past 4 weeks if fatigue predated the change; otherwise, started or changed regimen in past 2 months
9. Untreated or under-treated major depressive disorder
10. Started antidepressant medication within past 6 weeks
11. Substance abuse/dependence (past 4 months)
12. Regular and frequent cannabis use (\> twice/week regularly)
13. Currently clinically significant suicidal ideation or Hamilton Depression Scale (HAM-D) score \>24
14. History or current psychosis or bipolar disorder
15. Pregnant or breastfeeding
16. Significant untreated insomnia (score \>3 on HAM-D insomnia items)
17. Currently taking psychostimulant medication or past nonresponse to modafinil
18. Has no alternative viable antiretroviral regimen after the current one
19. Left ventricular hypertrophy; mitral valve prolapse
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT00737204
Study Brief:
Protocol Section:
NCT00737204