Search / Trial NCT00001079

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

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Trial Information

Current as of December 03, 2023

Completed

Keywords

Placebos Drug Therapy, Combination Acquired Immunodeficiency Syndrome Aids Related Complex Hiv Wasting Syndrome Megestrol Acetate Dihydrotestosterone Heptanoate

Description

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).

Attachments

readout_NCT00001079_2023-12-03.pdf

4.5 MB

NCT00001079_study_protocol.pdf

4.5 MB

About company

The National Institute of Allergy and Infectious Diseases (NIAID, /ˈnaɪ.æd/) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services (HHS). NIAID's mission is to conduct basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases.

Contacts

JC

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

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Reviews (48)

4.6

All reviews come from applied patients

5 stars
41
4 stars
6
3 stars
2
2 stars
0
1 stars
0
Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Michael Foster
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Dries Vincent
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

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