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

Sponsor:	National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by:	National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:	NCT00000854

Purpose

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	Intervention	Phase
HIV Infections HIV Wasting Syndrome	Drug: Nandrolone decanoate	Phase I

Study Type:	Interventional
Study Design:	Treatment, Parallel Assignment, Safety Study
Official Title:	A Randomized, Double-Blind, Placebo-Controlled, Phase I/II Trial of Nandrolone Decanoate in Women With HIV-Associated Weight Loss

Resource links provided by NLM:

MedlinePlus related topics: AIDS Weight Control

Drug Information available for: Nandrolone phenpropionate Nandrolone decanoate Nandrolone

U.S. FDA Resources

Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Estimated Enrollment:	38
Study Start Date:	December 1996

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.

Eligibility

Ages Eligible for Study:	13 Years and older
Genders 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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00000854

Hide Study Locations

Locations

United States, California
Univ of California / San Diego Treatment Ctr
San Diego, California, United States, 921036325
San Francisco Gen Hosp
San Francisco, California, United States, 941102859
UCLA CARE Ctr
Los Angeles, California, United States, 90095
Univ of Southern California / LA County USC Med Ctr
Los Angeles, California, United States, 900331079
United States, Colorado
Univ of Colorado Health Sciences Ctr
Denver, Colorado, United States, 80262
United States, District of Columbia
Howard Univ
Washington, District of Columbia, United States, 20059
United States, Hawaii
Queens Med Ctr
Honolulu, Hawaii, United States, 96816
Univ of Hawaii
Honolulu, Hawaii, United States, 96816
United States, Illinois
Northwestern Univ Med School
Chicago, Illinois, United States, 60611
United States, Louisiana
Charity Hosp / Tulane Univ Med School
New Orleans, Louisiana, United States, 70112
United States, Maryland
Johns Hopkins Hosp
Baltimore, Maryland, United States, 21287
United States, Massachusetts
Beth Israel Deaconess - West Campus
Boston, Massachusetts, United States, 02215
United States, Missouri
St Louis Regional Hosp / St Louis Regional Med Ctr
St. Louis, Missouri, United States, 63112
United States, New York
Univ of Rochester Medical Center
Rochester, New York, United States, 14642
Beth Israel Med Ctr
New York, New York, United States, 10003
United States, North Carolina
Univ of North Carolina
Chapel Hill, North Carolina, United States, 275997215
Duke Univ Med Ctr
Durham, North Carolina, United States, 27710
United States, Ohio
Univ of Cincinnati
Cincinnati, Ohio, United States, 452670405
United States, Pennsylvania
Univ of Pennsylvania at Philadelphia
Philadelphia, Pennsylvania, United States, 19104
United States, South Carolina
Julio Arroyo
West Columbia, South Carolina, United States, 29169
Puerto Rico
Univ of Puerto Rico
San Juan, Puerto Rico, 009365067

Sponsors and Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

Study Chair:	K Mulligan
Study Chair:	R Clark
Study Chair:	J Currier

More Information

Publications:

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.

Mulligan K, Zackin R, Clark RA, Sattler FR, Santana J, Delvers T, Currier JS. Nandrolone decanoate increases weight and lean body mass in HIV-infected women with weight loss: a randomized, double-blind, placebo-controlled, multicenter trial. 8th Conf Retro and Opportun Infect. 2001 Feb 4-8 (abstract no 641)

Study ID Numbers:	ACTG 329
Study First Received:	November 2, 1999
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00000854 History of Changes
Health Authority:	United States: Federal Government

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:

Sexually Transmitted Diseases, Viral
Slow Virus Diseases
HIV Wasting Syndrome
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Infection
Hormones
Body Weight
Nandrolone
Signs and Symptoms
Pathologic Processes
Syndrome
Weight Loss
Body Weight Changes
Nandrolone decanoate

Nutrition Disorders
Retroviridae Infections
RNA Virus Infections
Nandrolone phenpropionate
Disease
Metabolic Diseases
Immune System Diseases
Acquired Immunodeficiency Syndrome
Pharmacologic Actions
Immunologic Deficiency Syndromes
Virus Diseases
Anabolic Agents
HIV Infections
Sexually Transmitted Diseases
Lentivirus Infections

ClinicalTrials.gov processed this record on November 27, 2009