HIV InfectionsPhase 1NCT00000854
A Study to Evaluate the Effect of Nandrolone Decanoate in Women With HIV-Associated Weight Loss
A Phase 1 study testing Nandrolone decanoate in people with HIV Infections and HIV Wasting Syndrome, run by National Institute of Allergy and Infectious Diseases (NIAID) at 22 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 13 years and older, women only
- Conditions the study is for
- HIV Infections, HIV Wasting Syndrome
- What is being tested?
- Nandrolone decanoate
- How many people
- 38 participants
- Where
- 22 sitesin 2 countries
- Study dates
- Start not givento May 2003
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 years and older
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Show all 9Show fewer
- 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.
Trial locations and contacts
22 sites in 2 countries.
22 sites in 2 countries
United States20 sites
University of Colorado Hospital CRS
Aurora, Colorado, 80045
Johns Hopkins Adult AIDS CRS
Baltimore, Maryland, 21287
Beth Israel Deaconess Med. Ctr., ACTG CRS
Boston, Massachusetts, 02215
Unc Aids Crs
Chapel Hill, North Carolina, 27514
Northwestern University CRS
Chicago, Illinois, 60611
Univ. of Cincinnati CRS
Cincinnati, Ohio, 45267
Duke Univ. Med. Ctr. Adult CRS
Durham, North Carolina, 27710
Queens Med. Ctr.
Honolulu, Hawaii, 96813
Univ. of Hawaii at Manoa, Leahi Hosp.
Honolulu, Hawaii, 96816
USC CRS
Los Angeles, California, 90033
UCLA CARE Center CRS
Los Angeles, California, 90035
Tulane Med. Ctr. - Charity Hosp. of New Orleans, ACTU
New Orleans, Louisiana, 70112
Beth Israel Med. Ctr. (Mt. Sinai)
New York, New York, 10003
Hosp. of the Univ. of Pennsylvania CRS
Philadelphia, Pennsylvania, 19104
Univ. of Rochester ACTG CRS
Rochester, New York, 14642
Ucsd, Avrc Crs
San Diego, California, 92103
Ucsf Aids Crs
San Francisco, California, 94110
Washington U CRS
St Louis, Missouri, 63110
St. Louis ConnectCare, Infectious Diseases Clinic
St Louis, Missouri, 63112
Howard University Hosp., Div. of Infectious Diseases, ACTU
Washington D.C., District of Columbia, 20060
Puerto Rico2 sites
Puerto Rico-AIDS CRS
San Juan, 00935
San Juan City Hosp. PR NICHD CRS
San Juan, 00936
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Phase I/II Trial of Nandrolone Decanoate in Women With HIV-Associated Weight Loss
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.
Read the 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.
- Conditions
- HIV Infections, HIV Wasting Syndrome
- Being tested
- Nandrolone decanoate
- Keywords
- Placebos, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Anabolic Steroids, HIV Wasting Syndrome, nandrolone decanoate
- Medical subject headings
- HIV Infections, HIV Wasting Syndrome, Acquired Immunodeficiency Syndrome, AIDS-Related Complex
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nandrolone decanoateDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2001 (estimated)
- Study completionMay 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Intervention model
- Parallel groups
- Enrolment
- 38 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- K Mulligan, Study chairR Clark, Study chairJ Currier, Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00000854
- Sponsor's protocol ID
- ACTG 329
- Other IDs
- 11301
- Status last verified
- Oct 2021
- First submitted
- 2 Nov 1999
- Last updated
- 29 Oct 2021
- Results posted
- No
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. doi: 10.1001/archinte.165.5.578.
PubMed 15767536
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Phase I/II Trial of Nandrolone Decanoate in Women With HIV-Associated Weight Loss
- ClinicalTrials.gov ID
- NCT00000854
- Acronym / sponsor ID
- ACTG 329
- Conditions
- HIV Infections, HIV Wasting Syndrome
- Keywords
- Placebos, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Anabolic Steroids, HIV Wasting Syndrome, nandrolone decanoate
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study completion
- May 2003 (actual)
- First posted
- 31 Aug 2001 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Intervention model
- Parallel groups
Who may qualify
- Ages
- 13 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (9 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nandrolone decanoate | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2021.
- Background: PubMed 15767536Mulligan 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
K Mulligan study chair
R Clark study chair
J Currier study chair
22 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Nandrolone decanoate in people with HIV Infections and HIV Wasting Syndrome, run by National Institute of Allergy and Infectious Diseases (NIAID) at 22 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00000854, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2021.