A Study to Evaluate the Effect of Nandrolone Decanoate in Women With HIV-Associated Weight Loss
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| ClinicalTrials.gov Identifier: NCT00000854 |
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Recruitment Status :
Completed
First Posted : August 31, 2001
Last Update Posted : February 14, 2012
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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 |
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.
| 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 |
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 13 Years and older (Child, Adult, Older Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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.
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
| United States, California | |
| USC CRS | |
| Los Angeles, California, United States, 90033 | |
| UCLA CARE Center CRS | |
| Los Angeles, California, United States, 90035 | |
| 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 | |
| Study Chair: | K Mulligan | ||
| Study Chair: | R Clark | ||
| Study Chair: | J Currier |
Publications:
| Responsible Party: | National Institute of Allergy and Infectious Diseases (NIAID) |
| ClinicalTrials.gov Identifier: | NCT00000854 History of Changes |
| 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):
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Placebos Acquired Immunodeficiency Syndrome AIDS-Related Complex |
Anabolic Steroids HIV Wasting Syndrome nandrolone decanoate |
Additional relevant MeSH terms:
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Syndrome HIV Infections Weight Loss Cachexia Wasting Syndrome HIV Wasting Syndrome Disease Pathologic Processes 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 Signs and Symptoms Emaciation Metabolic Diseases Nutrition Disorders Decanoic acid Nandrolone Nandrolone decanoate Nandrolone phenpropionate Antifungal Agents Anti-Infective Agents Androgens Hormones |