A Study of Megestrol Acetate Alone or in Combination With Testosterone Enanthate Drug in the Treatment of HIV-Associated Weight Loss

Exclusion Criteria

• •Co-existing Condition:
• •Patients with any of the following symptoms or conditions are excluded:
• •Diabetes mellitus.
• •Diarrhea defined as 4 or more liquid or watery stools per day while using antidiarrheal medication.
• •Tube feeding. AS PER AMENDMENT 9/26/97: Total or partial parenteral nutrition delivered centrally or peripherally.
• •Impaired oral intake due to mucositis of any cause.
• •Grade 2 or greater intractable nausea and vomiting despite medication.
• •Cardiomyopathy or congestive heart failure.
• •Persistent palpable dominant breast mass at study entry that has not been worked up - males and females.
• •Female patients:
• •Pap smear or cervical biopsy that demonstrates high grade squamous intraepithelial lesions or cervical intraepithelial lesions 2 or worse.
• •Concurrent Medication:
• •Excluded:
• •Systemic chemotherapy for B-cell lymphoma or malignancies other than Kaposi's sarcoma. (Patients with Kaposi's sarcoma receiving systemic chemotherapy will not be excluded.)
• •Total or peripheral parenteral nutrition (oral supplements are not excluded).
• •Anticoagulant therapy.
• •Any drug that is designed to affect appetite or weight gain. AS PER AMENDMENT 9/26/97: Initiation of any new therapy designed to promote weight gain.
• •Any change of antiretroviral or any change in the dosage of antiretroviral/s that had not been started 30 days pre-entry. AS PER AMENDMENT 9/26/97: Initiation of antiretroviral therapy within 12 weeks of protocol therapy for patients not previously receiving antiretroviral therapy.
• •Anabolic hormones.
• •Systemic glucocorticoids.
• •Cytokine inhibitors.
• •Oral contraceptives.
• •Cytokines.
• •Ketoconazole.
• •Any other medication that might interfere with the objectives of this study.
• •AS PER AMENDMENT 9/26/97:DHEA.
• •Patients with the following prior conditions will be excluded:
• •Acute systemic opportunistic infections within 30 days prior to entry.
• •Weight gain \>= 3% as documented by self reporting or clinical records during the preceding 4 weeks. AS PER AMENDMENT 9/26/97: Enrollment of such patients should be deferred until weight stabilizes.
• •History of hypersensitivity reaction to megestrol acetate or testosterone enanthate.
• •History of cardiomyopathy or congestive heart failure.
• •Female patients:
• •History of invasive cervical cancer.
• •AS PER AMENDMENT 9/26/97: History of thromboemboli.
• •Prior Medication:
• •Excluded:
• •No testosterone treatment within the previous 8 weeks.
• •Excluded within 30 days prior to entry:
• •Ketoconazole.
• •Initiation or change in antiretroviral therapy.
• •Interleukins.
• •Interferon, anabolic, hormonal or experimental therapies designed to improve appetite or weight gain (e.g., thalidomide, dronabinol, megestrol acetate, cyproheptadine, anabolic steroids, systemic glucocorticoids, pentoxifylline, or growth hormone).
• •AS PER AMENDMENT 9/26/97: Dehydroepiandrosterone (DHEA).