Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001079
Status:
COMPLETED
Last Update Posted:
2021-11-01
First Post:
1999-11-02
Brief Title:
A Study of Megestrol Acetate Alone or in Combination With Testosterone Enanthate Drug in the Treatment of 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:
Double-Blind Randomized Comparison Phase II Trial of Megestrol Acetate and Testosterone Enanthate in Combination Versus Megestrol Acetate Plus Testosterone Enanthate Placebo in Human Immunodeficiency Virus HIV-Associated Wasting
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:
To test the hypothesis that the predominant accrual of fat rather than lean body mass LBM that occurs during treatment of HIV-associated wasting with megestrol acetate may be improved by treatment with megestrol acetate and testosterone enanthate in combination
Body wasting is an increasingly frequent AIDS-defining condition in individuals infected with HIV Increasing caloric intake fails to consistently restore lean tissue patients with HIV associated weight loss Megestrol acetate has been shown to stimulate appetite and weight gain in subjects with cancer and in those with HIV associated weight loss However the weight gained during treatment with megestrol acetate was predominantly or exclusively fat An important factor is the preferential increase in body fat seen in both of these studies may have been due to hypogonadism that occurs as a result of treatment with megestrol acetate a progestational agent Hypogonadism is associated with an increase in body fat and a decrease in LBM Concomitant testosterone replacement should substantially increase the amount of LBM accrued during megestrol acetate therapy This study will determine whether anabolic potential can be realized when caloric intake is increased in the absence of concomitant hypogonadism
Body wasting is an increasingly frequent AIDS-defining condition in individuals infected with HIV Increasing caloric intake fails to consistently restore lean tissue patients with HIV associated weight loss Megestrol acetate has been shown to stimulate appetite and weight gain in subjects with cancer and in those with HIV associated weight loss However the weight gained during treatment with megestrol acetate was predominantly or exclusively fat An important factor is the preferential increase in body fat seen in both of these studies may have been due to hypogonadism that occurs as a result of treatment with megestrol acetate a progestational agent Hypogonadism is associated with an increase in body fat and a decrease in LBM Concomitant testosterone replacement should substantially increase the amount of LBM accrued during megestrol acetate therapy This study will determine whether anabolic potential can be realized when caloric intake is increased in the absence of concomitant hypogonadism
Detailed Description:
Body wasting is an increasingly frequent AIDS-defining condition in individuals infected with HIV Increasing caloric intake fails to consistently restore lean tissue patients with HIV associated weight loss Megestrol acetate has been shown to stimulate appetite and weight gain in subjects with cancer and in those with HIV associated weight loss However the weight gained during treatment with megestrol acetate was predominantly or exclusively fat An important factor is the preferential increase in body fat seen in both of these studies may have been due to hypogonadism that occurs as a result of treatment with megestrol acetate a progestational agent Hypogonadism is associated with an increase in body fat and a decrease in LBM Concomitant testosterone replacement should substantially increase the amount of LBM accrued during megestrol acetate therapy This study will determine whether anabolic potential can be realized when caloric intake is increased in the absence of concomitant hypogonadism
This is a 24 week study consisting of a 12 week double blind randomized comparison Phase II trial of megestrol acetate and testosterone enanthate in combination versus megestrol acetate plus testosterone enanthate placebo in HIV associated wasting and a 12 week open label follow up of the combination therapy
This is a 24 week study consisting of a 12 week double blind randomized comparison Phase II trial of megestrol acetate and testosterone enanthate in combination versus megestrol acetate plus testosterone enanthate placebo in HIV associated wasting and a 12 week open label follow up of the combination therapy
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 |
|---|---|---|---|
| 11288 | REGISTRY | DAIDS ES | None |