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

Inclusion Criteria

Concurrent Medication:

Allowed:

• Stable antiretroviral therapy provided the patient has been on it for >=30 days prior to study entry. AS PER AMENDMENT 9/26/97: Optimized antiretroviral therapy as determined by primary care provider with at least 30 days since initiation of such therapy.
• Standard maintenance and prophylaxis therapy for opportunistic infections is permitted provided patients have been on a stable dosage regimen for 2 weeks prior to screening.
• G-CSF.
• Erythropoietin.
• Any symptomatic therapy (e.g., analgesics, antihistamines, antiemetic, antidiarrheal agents, etc.).
• Replacement levels of thyroid drugs (same drug and dose as at 30 days pre-entry).
• Maintenance therapy is permitted for chronic opportunistic infections, but patient must be on a stable regimen for 14 days pre-entry.
• AS PER AMENDMENT 9/26/97: Oral nutritional supplements, dronabinol, cyproheptadine, or pentoxifylline.

Patients must have:

• Documented HIV-1 infection.
• Documented weight loss of > 10% pre-illness weight or Body Mass Index < 18.5 kg/m2. AS PER AMENDMENT 9/26/97: Documented weight loss of >= 5% pre-illness weight or Body Mass Index < 20 kg/m2.
• Life expectancy of at least 6 months.

NOTE:

• This protocol meets federal requirements governing prisoner participation in clinical trials.

Prior Medication:

Allowed:

• Stable (no change in drugs or dosage) antiretroviral therapy or no antiretroviral medications for >= 30 days prior to the study entry.

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).