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 @ 12:22 AM
Ignite Modification Date:
2025-12-25 @ 12:22 AM
NCT ID:
NCT00006158
Eligibility Criteria:
Inclusion Criteria:
* Females using acceptable form of birth control during study, including barrier contraception or IUD but excluding oral contraceptives or Depo-Provera
* Documented HIV infection
* Free testosterone level 3.0 pg/mL
* Weight \< 90% or weight loss \> 10% of pre-illness weight
Exclusion Criteria:
* Pregnant or actively seeking pregnancy
* Breast feeding
* New opportunistic infection diagnosed within 4 weeks of the study
* Requiring parenteral nutrition or pharmacologic glucocorticoid therapy
* Intractable diarrhea (6 stools/day)
* Androgen, estrogen, progestational derivative, or glucocorticoid administration within 3 months of the study, including Megace
* New retroviral therapy within 6 weeks of study
* SGOT \> 5 X normal and/or clinically significant liver disease
* Creatinine \> 2.0 mg/dL and/or clinically significant renal disease
* Hgb \< 8.0 g/dL
* Active substance abuse or alcoholism
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT00006158
Study Brief:
Protocol Section:
NCT00006158