Clinical trial NCT00000854: A Study to Evaluate the Effect of Nandrolone Decanoate in Women With HIV-Associated Weight Loss
Official title: A Randomized, Double-Blind, Placebo-Controlled, Phase I/II Trial of Nandrolone Decanoate in Women With HIV-Associated Weight Loss
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: HIV Infections
HIV Wasting Syndrome
Keywords: Placebos
Acquired Immunodeficiency Syndrome
AIDS-Related Complex
Anabolic Steroids
HIV Wasting Syndrome
nandrolone decanoate
Lead sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Sponsor class: NIH
First posted: 2001-08-31
Enrollment: 38
Sex: FEMALE
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: USC CRS
state: California
city: Los Angeles
country: United States
facility: UCLA CARE Center CRS
state: California
city: San Diego
country: United States
facility: Ucsd, Avrc Crs
state: California
city: San Francisco
country: United States
facility: Ucsf Aids Crs
state: California
city: Aurora
country: United States
facility: University of Colorado Hospital CRS
state: Colorado
city: Washington
country: United States
facility: Howard University Hosp., Div. of Infectious Diseases, ACTU
state: District of Columbia
city: Honolulu
country: United States
facility: Queens Med. Ctr.
state: Hawaii
city: Honolulu
country: United States
facility: Univ. of Hawaii at Manoa, Leahi Hosp.
state: Hawaii
city: Chicago
country: United States
facility: Northwestern University CRS
state: Illinois
city: New Orleans
country: United States
facility: Tulane Med. Ctr. - Charity Hosp. of New Orleans, ACTU
state: Louisiana
city: Baltimore
country: United States
facility: Johns Hopkins Adult AIDS CRS
state: Maryland
city: Boston
country: United States
facility: Beth Israel Deaconess Med. Ctr., ACTG CRS
state: Massachusetts
city: Saint Louis
country: United States
facility: Washington U CRS
state: Missouri
city: Saint Louis
country: United States
facility: St. Louis ConnectCare, Infectious Diseases Clinic
state: Missouri
city: New York
country: United States
facility: Beth Israel Med. Ctr. (Mt. Sinai)
state: New York
city: Rochester
country: United States
facility: Univ. of Rochester ACTG CRS
state: New York
city: Chapel Hill
country: United States
facility: Unc Aids Crs
state: North Carolina
city: Durham
country: United States
facility: Duke Univ. Med. Ctr. Adult CRS
state: North Carolina
city: Cincinnati
country: United States
facility: Univ. of Cincinnati CRS
state: Ohio
city: Philadelphia
country: United States
facility: Hosp. of the Univ. of Pennsylvania CRS
state: Pennsylvania
city: San Juan
country: Puerto Rico
facility: Puerto Rico-AIDS CRS
city: San Juan
country: Puerto Rico
facility: San Juan City Hosp. PR NICHD CRS
Study officials:
name: K Mulligan
role: STUDY_CHAIR
name: R Clark
role: STUDY_CHAIR
name: J Currier
role: STUDY_CHAIR
References:
citation: 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.