Search / Trial NCT00000854

A Study to Evaluate the Effect of Nandrolone Decanoate in Women With 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 February 21, 2024

Completed

Keywords

Placebos Acquired Immunodeficiency Syndrome Aids Related Complex Anabolic Steroids Hiv Wasting Syndrome Nandrolone Decanoate

Description

Body wasting is an increasingly frequent AIDS-defining condition and it is becoming evident that women are not exempt from this complication of HIV. Although multicenter trials of megestrol acetate, dronabinol and growth hormone have not specifically excluded women, women have generally been underrepresented in these trials. This study hopes to generate data that will be substantial enough to perform an analysis that might determine whether there are gender-based differences in anabolic potential. Patients will be randomized to receive either nandrolone decanoate or placebo every 2 weeks f...

Gender

Female

Eligibility criteria

  • Inclusion Criteria
  • You may be eligible for this study if you:
  • Are an HIV-positive woman over 13 years old (need consent if under 18).
  • Have lost weight over the past 12 months.
  • Are able to eat almost enough to maintain your current weight.
  • Agree to practice abstinence or use effective methods of birth control.
  • Are on a stable anti-HIV drug regimen or have not been on any anti-HIV drug regimen for the past 30 days.
  • Exclusion Criteria
  • You will not be eligible for this study if you:
  • Are allergic to nandrolone.
  • Have a history of cervical cancer, diabetes, cardiomyopathy or congestive heart failure, or are taking certain medications.
  • Have an active opportunistic (HIV-associated) infection or another major illness within 30 days of study entry.
  • Have an abnormal PAP smear.
  • Have difficulty eating (are on tube-feeding, for example).
  • Have severe nausea, vomiting, or diarrhea.
  • Have Kaposi's sarcoma (unless stable) or are receiving chemotherapy or radiation for any type of cancer.
  • Are pregnant or breast-feeding.

Attachments

readout_NCT00000854_2024-02-21.pdf

4.5 MB

NCT00000854_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 Diego, 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

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

Rochester, New York, United States

Chapel Hill, North Carolina, United States

Durham, North Carolina, United States

Cincinnati, Ohio, United States

Philadelphia, Pennsylvania, United States

San Juan, , Puerto Rico

San Juan, , Puerto Rico

Honolulu, Hawaii, 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
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2 stars
0
1 stars
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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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