A Study to Evaluate the Effect of Nandrolone Decanoate in Women With HIV-Associated Weight Loss
NCT ID: NCT00000854
Last Updated: 2021-10-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
38 participants
INTERVENTIONAL
2003-05-31
Brief Summary
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Wasting has become an AIDS-defining condition. In the past, most studies that examined wasting treatments were limited to men. However, it appears that wasting in HIV-positive men is linked to levels of testosterone (a hormone which affects men's bodies more than women's). This study has been designed for women only, in order to best treat wasting in HIV-positive women.
Detailed Description
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Patients will be randomized to receive either nandrolone decanoate or placebo every 2 weeks for 12 weeks of the study. All patients who complete the first 12 weeks of the study will be eligible to receive open-label nandrolone for the subsequent 12 weeks.
Conditions
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Keywords
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Study Design
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PARALLEL
TREATMENT
Interventions
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Nandrolone decanoate
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
13 Years
FEMALE
No
Sponsors
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National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Responsible Party
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Principal Investigators
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K Mulligan
Role: STUDY_CHAIR
R Clark
Role: STUDY_CHAIR
J Currier
Role: STUDY_CHAIR
Locations
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USC CRS
Los Angeles, California, United States
UCLA CARE Center CRS
Los Angeles, California, United States
Ucsd, Avrc Crs
San Diego, 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
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
Washington U CRS
St Louis, Missouri, United States
St. Louis ConnectCare, Infectious Diseases Clinic
St Louis, Missouri, United States
Beth Israel Med. Ctr. (Mt. Sinai)
New York, New York, United States
Univ. of Rochester ACTG CRS
Rochester, New York, United States
Unc Aids Crs
Chapel Hill, North Carolina, 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
Puerto Rico-AIDS CRS
San Juan, , Puerto Rico
San Juan City Hosp. PR NICHD CRS
San Juan, , Puerto Rico
Countries
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References
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Mulligan K, Zackin R, Clark RA, Alston-Smith B, Liu T, Sattler FR, Delvers TB, Currier JS; AIDS Clinical Trials Group 329 Study Team; National Institute of Allergy and Infectious Diseases Adult AIDS Clinical Trials Group. Effect of nandrolone decanoate therapy on weight and lean body mass in HIV-infected women with weight loss: a randomized, double-blind, placebo-controlled, multicenter trial. Arch Intern Med. 2005 Mar 14;165(5):578-85. doi: 10.1001/archinte.165.5.578.
Other Identifiers
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11301
Identifier Type: REGISTRY
Identifier Source: secondary_id
ACTG 329
Identifier Type: -
Identifier Source: org_study_id