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:
2025-12-25 @ 4:11 AM
Ignite Modification Date:
2025-12-25 @ 4:11 AM
NCT ID:
NCT01023620
Eligibility Criteria:
Inclusion Criteria:
Participants must be 18 years of age or older of all racial and ethnic origins, and capable of giving informed consent. Spanish speaking individuals are eligible for participation.
Additionally they must be/have:
1. Biologically male (not transgendered)
2. HIV positive for at least 24 months,
3. On stable HAART for at least the last 3 months prior to entering the study,
4. Practitioner diagnosed lipodystrophy as defined by:
aHAL (any of these) decreased subcutaneous fat in the limbs with prominent veins, loss of buttock fat or facial atrophy hHAL: fat accumulation in abdomen and/or dorsocervical region
Exclusion Criteria:
Participants cannot be less than 18 years of age, institutionalized, nor have prior diseases or conditions that may alter body fat composition. Exclusions:
1. Females are excluded
2. Prior history of CHF
3. Prior history of macular retinal edema
4. Prior history of spontaneous bone fracture
5. Diabetics receiving oral/injected/inhaled diabetic agents or individuals with a fasting blood glucose value greater than or equal to 140 within the last 90 days.
6. Current active opportunistic infections for example :
1. PCP pneumonia
2. Neuropathy
3. Thrush
4. Systemic KS (Kaposi sarcoma)
i) localized cutaneous lesions are not an exclusion e) MAC (Mycobacterium Avium complex) f) Histoplasmosis g) Coccidioidomycosis
7. Planning to discontinue HAART
8. Current diagnosis of cancer or receiving chemotherapy
9. Systemic steroid use during the prior 6 months
10. Hepatitis C+ or previous diagnosis of cirrhosis
11. Liver Function Studies great than or equal to triple of normal values
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT01023620
Study Brief:
Protocol Section:
NCT01023620