Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000737
Status:
COMPLETED
Last Update Posted:
2008-08-25
First Post:
1999-11-02
Brief Title:
A Phase III Study to Evaluate Single Agent and Combination Therapy With Megestrol Acetate and Dronabinol for the Treatment of HIV-Wasting Syndrome
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Phase III Study to Evaluate Single Agent and Combination Therapy With Megestrol Acetate and Dronabinol for the Treatment of HIV-Wasting Syndrome
Status:
COMPLETED
Status Verified Date:
1994-01
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 obtain data on the safety of administering megestrol acetate and dronabinol as single agents or in combination to patients with human immunodeficiency virus HIV-wasting syndrome To obtain preliminary data on the efficacy of single agent and combination therapy with megestrol acetate and dronabinol with regard to weight gain appetite increase and quality of life in this patient population To obtain steady-state pharmacokinetics data when megestrol acetate and dronabinol are administered as single agents and in combination
HIV-wasting syndrome which is characterized by severely debilitating anorexia and weight loss is of particular concern because it can exacerbate the primary illness and is associated with a poor prognosis Attempts at maintaining body mass through the use of megestrol acetate and dronabinol two anti-cachectic drugs may prolong survival
HIV-wasting syndrome which is characterized by severely debilitating anorexia and weight loss is of particular concern because it can exacerbate the primary illness and is associated with a poor prognosis Attempts at maintaining body mass through the use of megestrol acetate and dronabinol two anti-cachectic drugs may prolong survival
Detailed Description:
HIV-wasting syndrome which is characterized by severely debilitating anorexia and weight loss is of particular concern because it can exacerbate the primary illness and is associated with a poor prognosis Attempts at maintaining body mass through the use of megestrol acetate and dronabinol two anti-cachectic drugs may prolong survival
Fifty-six patients are randomized to one of four treatment arms as follows high-dose megestrol acetate alone dronabinol alone high-dose megestrol acetate combined with dronabinol or low-dose megestrol acetate combined with dronabinol Treatment continues for 12 weeks Patients are evaluated for toxicity preliminary evidence of response eg weight gain and steady-state pharmacokinetics of drug therapies
Fifty-six patients are randomized to one of four treatment arms as follows high-dose megestrol acetate alone dronabinol alone high-dose megestrol acetate combined with dronabinol or low-dose megestrol acetate combined with dronabinol Treatment continues for 12 weeks Patients are evaluated for toxicity preliminary evidence of response eg weight gain and steady-state pharmacokinetics of drug therapies
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?: