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A Study to Evaluate the Effect of Nandrolone Decanoate in Women With HIV-Associated Weight Loss

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00000854
Recruitment Status : Completed
First Posted : August 31, 2001
Last Update Posted : February 14, 2012
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)

Brief Summary:

The purpose of this study is to see if giving nandrolone decanoate (a hormonal drug) will cause weight gain in HIV-positive women who have HIV-associated weight loss (wasting).

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.


Condition or disease Intervention/treatment Phase
HIV Infections HIV Wasting Syndrome Drug: Nandrolone decanoate Phase 1

Detailed 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 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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 38 participants
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Phase I/II Trial of Nandrolone Decanoate in Women With HIV-Associated Weight Loss
Actual Study Completion Date : May 2003

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Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00000854


Locations
Show Show 22 study locations
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
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Study Chair: K Mulligan
Study Chair: R Clark
Study Chair: J Currier
Publications:
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Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00000854    
Other Study ID Numbers: ACTG 329
11301 ( Registry Identifier: DAIDS ES )
First Posted: August 31, 2001    Key Record Dates
Last Update Posted: February 14, 2012
Last Verified: February 2012
Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Placebos
Acquired Immunodeficiency Syndrome
AIDS-Related Complex
Anabolic Steroids
HIV Wasting Syndrome
nandrolone decanoate
Additional relevant MeSH terms:
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HIV Wasting Syndrome
Wasting Syndrome
Syndrome
Weight Loss
Cachexia
Disease
Pathologic Processes
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Body Weight Changes
Body Weight
Emaciation
Metabolic Diseases
Nutrition Disorders
Nandrolone Decanoate
Nandrolone
Nandrolone phenpropionate
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anabolic Agents
Bone Density Conservation Agents