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

Completed · Phase 2

Conditions studied: HIV Infections, HIV Wasting Syndrome

In brief

To test the hypothesis that the predominant accrual of fat rather than lean body mass (LBM) that occurs during treatment of HIV-associated wasting with megestrol acetate may be improved by treatment with megestrol acetate and testosterone enanthate in combination. Body wasting is an increasingly frequent AIDS-defining condition in individuals infected with HIV. Increasing caloric intake fails to consistently restore lean tissue patients with HIV associated weight loss. Megestrol acetate has been shown to stimulate appetite and weight gain in subjects with cancer and in those with HIV associated weight loss. However, the weight gained during treatment with megestrol acetate was predominantly or exclusively fat. An important factor is the preferential increase in body fat seen in both of these studies may have been due to hypogonadism that occurs as a result of treatment with megestrol acetate, a progestational agent. Hypogonadism is associated with an increase in body fat and a decrease in LBM. Concomitant testosterone replacement should substantially increase the amount of LBM accrued during megestrol acetate therapy. This study will determine whether anabolic potential can be realized when caloric intake is increased in the absence of concomitant hypogonadism.

Key facts

Study ID

NCT00001079

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

80

Expected to finish

2002-12-01

Last updated by the study team

2021-11-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• USC CRS — Los Angeles, California, United States
• UCLA CARE Center CRS — Los Angeles, California, United States
• Ucsf Aids Crs — San Francisco, California, United States
• University of Colorado Hospital CRS — Aurora, Colorado, United States
• Howard University Hosp., Div. of Infectious Diseases, ACTU — Washington D.C., District of Columbia, United States
• Queens Med. Ctr. — Honolulu, Hawaii, United States
• Univ. of Hawaii at Manoa, Leahi Hosp. — Honolulu, Hawaii, United States
• Northwestern University CRS — Chicago, Illinois, United States
• Indiana Univ. School of Medicine, Infectious Disease Research Clinic — Indianapolis, Indiana, United States
• Indiana Univ. School of Medicine, Wishard Memorial — Indianapolis, Indiana, United States
• Tulane Med. Ctr. - Charity Hosp. of New Orleans, ACTU — New Orleans, Louisiana, United States
• Johns Hopkins Adult AIDS CRS — Baltimore, Maryland, United States
• Beth Israel Deaconess Med. Ctr., ACTG CRS — Boston, Massachusetts, United States
• St. Louis ConnectCare, Infectious Diseases Clinic — St Louis, Missouri, United States
• Washington U CRS — St Louis, Missouri, United States
• Beth Israel Med. Ctr. (Mt. Sinai) — New York, New York, United States
• Cornell University A2201 — New York, New York, United States
• Memorial Sloan-Kettering Cancer Ctr. — New York, New York, United States
• Duke Univ. Med. Ctr. Adult CRS — Durham, North Carolina, United States
• Univ. of Cincinnati CRS — Cincinnati, Ohio, United States
• Hosp. of the Univ. of Pennsylvania CRS — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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