Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000854
Status:
COMPLETED
Last Update Posted:
2021-10-29
First Post:
1999-11-02
Brief Title:
A Study to Evaluate the Effect of Nandrolone Decanoate in Women With HIV-Associated Weight Loss
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Randomized Double-Blind Placebo-Controlled Phase III Trial of Nandrolone Decanoate in Women With HIV-Associated Weight Loss
Status:
COMPLETED
Status Verified Date:
2021-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 mens bodies more than womens This study has been designed for women only in order to best treat wasting in HIV-positive women
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 mens bodies more than womens 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
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 Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 11301 | REGISTRY | DAIDS ES | None |