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

Further Study Details: 

Expected Total Enrollment:  38

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.

Ages Eligible for Study:  13 Years and above,  Genders Eligible for Study:  Female

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.

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

Study chairs or principal investigators

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

Study ID Numbers:  ACTG 329
Record last reviewed:  February 2003
Last Updated:  October 13, 2004
Record first received:  November 2, 1999
ClinicalTrials.gov Identifier:  NCT00000854
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08