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 (Responsible Party):	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:	Endpoint Classification: Safety Study 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

Resource links provided by NLM:

Genetics Home Reference related topics: complement factor I deficiency

MedlinePlus related topics: HIV/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 Completion Date:	May 2003

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

Locations

United States, California
UCLA CARE Center CRS
Los Angeles, California, United States, 90035
USC CRS
Los Angeles, California, United States, 90033
Ucsd, Avrc Crs
San Diego, California, United States, 92103
Ucsf Aids Crs
San Francisco, California, United States, 94110
United States, Colorado
University of Colorado Hospital CRS
Aurora, Colorado, United States, 80045
United States, District of Columbia
Howard University Hosp., Div. of Infectious Diseases, ACTU
Washington, District of Columbia, United States, 20060
United States, Hawaii
Queens Med. Ctr.
Honolulu, Hawaii, United States, 96813
Univ. of Hawaii at Manoa, Leahi Hosp.
Honolulu, Hawaii, United States, 96816
United States, Illinois
Northwestern University CRS
Chicago, Illinois, United States, 60611
United States, Louisiana
Tulane Med. Ctr. - Charity Hosp. of New Orleans, ACTU
New Orleans, Louisiana, United States, 70112
United States, Maryland
Johns Hopkins Adult AIDS CRS
Baltimore, Maryland, United States, 21287
United States, Massachusetts
Beth Israel Deaconess Med. Ctr., ACTG CRS
Boston, Massachusetts, United States, 02215
United States, Missouri
St. Louis ConnectCare, Infectious Diseases Clinic
St Louis, Missouri, United States, 63112
Washington U CRS
St. Louis, Missouri, United States, 63110
United States, New York
Beth Israel Med. Ctr. (Mt. Sinai)
New York, New York, United States, 10003
Univ. of Rochester ACTG CRS
Rochester, New York, United States, 14642
United States, North Carolina
Unc Aids Crs
Chapel Hill, North Carolina, United States, 27514
Duke Univ. Med. Ctr. Adult CRS
Durham, North Carolina, United States, 27710
United States, Ohio
Univ. of Cincinnati CRS
Cincinnati, Ohio, United States, 45267
United States, Pennsylvania
Hosp. of the Univ. of Pennsylvania CRS
Philadelphia, Pennsylvania, United States, 19104
Puerto Rico
Puerto Rico-AIDS CRS
San Juan, Puerto Rico, 00935
San Juan City Hosp. PR NICHD CRS
San Juan, Puerto Rico, 00936

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)

Responsible Party:	National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:	NCT00000854 History of Changes
Other Study ID Numbers:	ACTG 329, 11301
Study First Received:	November 2, 1999
Last Updated:	February 13, 2012
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:

HIV Infections
Acquired Immunodeficiency Syndrome
Wasting Syndrome
Weight Loss
HIV Wasting Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

Metabolic Diseases
Nutrition Disorders
Body Weight Changes
Body Weight
Signs and Symptoms
Nandrolone decanoate
Nandrolone
Nandrolone phenpropionate
Anabolic Agents
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Androgens

ClinicalTrials.gov processed this record on February 13, 2012