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 @ 9:40 PM
Ignite Modification Date:
2025-12-24 @ 9:40 PM
NCT ID:
NCT00111332
Eligibility Criteria:
Inclusion Criteria:
* Subjects with documented HIV infection, by Western blot or ELISA
* Ages 18-60
* Self-report AND physical evidence, as assessed by the investigators, of at least one of the following:
* increased abdominal girth;
* relative loss of fat in the face;
* relative loss of fat in the extremities; \*dorsocervical fat pad;
* relative increased breast size;
* a score greater than or equal to 1.5 on the Lipodystrophy Scale and a waist to hip ratio of greater than or equal to 0.85.
Exclusion Criteria:
* Pregnant or actively seeking pregnancy
* Breastfeeding
* New opportunistic infection diagnosed within 4 weeks of the study
* Pharmacologic glucocorticoid therapy (\> 7.5 mg Prednisone or its equivalent/day)
* Androgen, growth hormone or Megace within 3 months of study initiation
* New anti-retroviral therapy within 1 month of the study
* SGOT \> 5x normal and/or clinically significant liver disease
* Creatinine \> 2.0 mg/dL and/or clinically significant renal disease
* Hemoglobin (Hgb) \< 8.0g/dL
* Active substance abuse
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT00111332
Study Brief:
Protocol Section:
NCT00111332