Ignite Creation Date:
2024-05-05 @ 9:57 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00009555
Status:
COMPLETED
Last Update Posted:
2021-11-01
First Post:
2001-02-01
Brief Title:
Testosterone for HIV-Positive Men With Reduced Serum Testosterone Levels and Abdominal Fat
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Prospective Multicenter Randomized Placebo-Controlled Trial of Physiologic Testosterone Supplementation for HIV-Positive Men With Mildly to Moderately Reduced Serum Testosterone Levels and Abdominal Obesity
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 treatment with testosterone will reduce abdominal fat in HIV-positive men
Many HIV patients on antiretroviral therapy show an increase in abdominal fat Studies have shown that treatment with testosterone may decrease abdominal fat This study will determine if testosterone will reduce abdominal fat in HIV patients
Many HIV patients on antiretroviral therapy show an increase in abdominal fat Studies have shown that treatment with testosterone may decrease abdominal fat This study will determine if testosterone will reduce abdominal fat in HIV patients
Detailed Description:
Reports suggest that many HIV-infected patients on antiretroviral therapy experience an increase in abdominal fat The mechanisms of abdominal fat accumulation in HIV-infected patients are not known Studies have shown treatment with testosterone gel reduces total body fat in young androgen-deficient men testosterone replacement in middle-aged men with mid-segment obesity decreases visceral fat and replacement doses of testosterone decrease fat mass and augment lean body mass in HIV-infected men with androgen deficiency Therefore there is a strong rationale for evaluating the effectiveness of testosterone replacement in HIV-infected men with visceral obesity and low testosterone levels
Patients are stratified based on their viral load Patients receive either testosterone gel or placebo applied to the skin once daily for 24 weeks Patients remain on their current antiretroviral regimens which are not supplied through the study Patients who receive testosterone during the first 24 weeks are eligible to receive it for an additional 24 weeks Patients on placebo are followed for an additional 24 weeks Clinical and laboratory evaluations for visceral fat changes are performed throughout the study
Patients are stratified based on their viral load Patients receive either testosterone gel or placebo applied to the skin once daily for 24 weeks Patients remain on their current antiretroviral regimens which are not supplied through the study Patients who receive testosterone during the first 24 weeks are eligible to receive it for an additional 24 weeks Patients on placebo are followed for an additional 24 weeks Clinical and laboratory evaluations for visceral fat changes are performed throughout the study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| AACTG A5079 | Registry Identifier | DAIDS ES | None |
| 10175 | REGISTRY | None | None |
| ACTG A5079 | None | None | None |