A Study of Megestrol Acetate Alone or in Combination With Testosterone Enanthate Drug in the Treatment of HIV-Associated Weight Loss
Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001
Trial Information
Current as of May 11, 2025
Completed
Keywords
ClinConnect Summary
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 ...
Gender
ALL
Eligibility criteria
- • 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).
About National Institute Of Allergy And Infectious Diseases (Niaid)
The National Institute of Allergy and Infectious Diseases (NIAID) is a key component of the National Institutes of Health (NIH) dedicated to advancing the understanding, prevention, and treatment of infectious and immune-mediated diseases. Through rigorous clinical trials, NIAID aims to foster innovative research that enhances public health and addresses global health challenges, including emerging infectious diseases and allergies. The institute collaborates with various partners, including academic institutions, industry, and international organizations, to translate scientific discoveries into effective therapies and vaccines. NIAID's commitment to high-quality clinical research is integral to improving health outcomes and informing policy decisions in the realm of infectious diseases and immunology.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Los Angeles, California, United States
Los Angeles, California, United States
San Francisco, California, United States
Aurora, Colorado, United States
Washington, District Of Columbia, United States
Honolulu, Hawaii, United States
Chicago, Illinois, United States
Indianapolis, Indiana, United States
New Orleans, Louisiana, United States
Baltimore, Maryland, United States
Boston, Massachusetts, United States
Saint Louis, Missouri, United States
Saint Louis, Missouri, United States
New York, New York, United States
New York, New York, United States
New York, New York, United States
Durham, North Carolina, United States
Cincinnati, Ohio, United States
Philadelphia, Pennsylvania, United States
Honolulu, Hawaii, United States
Indianapolis, Indiana, United States
Patients applied
Trial Officials
Schambelan M
Study Chair
Mulligan K
Study Chair
Von Roenn JH
Study Chair
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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