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 @ 12:33 AM
Ignite Modification Date:
2025-12-25 @ 12:33 AM
NCT ID:
NCT00006167
Eligibility Criteria:
Inclusion Criteria:
* Loss of 10% of usual body weight, OR loss of 5% of usual body weight within the previous 6 months, OR BMI20kg/m2. If the candidate is taking a protease inhibitor, he/she must have not regained weight since initiating the medication over a period of at least 4 weeks prior to screening.
* Documented HIV-positive
* Able to eat
* English-speaking
* Compliance with medical regimens
* For heterosexually active women: willingness to use an effective means of birth control
* Patient and physician not planning to start new treatments for HIV infection or weight loss during the 12 weeks of study.
Exclusion Criteria:
* Vomiting 1 time/day or diarrhea 4 times/day on average in the previous week
* Fever 101 F within the previous week
* Receiving induction treatment for one of the following (new diagnosis or recurrence within 4 weeks):
Pneumocystis carinii pneumonia Cryptococcal meningitis Cytomegalovirus retinitis or pneumonitis Toxoplasmosis Mycobacterium avium complex Visceral Kaposi's Sarcoma Lymphoma Pulmonary tuberculosis
* Received corticosteroids, estrogens, progesterones, androgens, oral anticoagulants, or growth hormone within the previous three months
* History of life-threatening reaction to oxandrolone or testosterone
* Currently pregnant
* History of congestive heart failure, myocardial infarction, angina/coronary artery disease, uncontrolled hypertension, cerebrovascular accident, hepatic failure, bleeding disorder, diabetes, nephrotic syndrome, cancer of the breast or prostate, or hypercalcemia
* Milk product allergy
* Current use of injected drugs
* Participation in an exercise program or strength training within the previous 4 weeks
* Any medical condition which renders the participant physically incapable of performing strength exercises
* Serum total testosterone level at least 300ng/ml, unless patient and primary physician prepared to begin testosterone injections concurrent with study enrollment (men only).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00006167
Study Brief:
Protocol Section:
NCT00006167