Overview

A Phase I/II Study to Evaluate Single Agent and Combination Therapy With Megestrol Acetate and Dronabinol for the Treatment of HIV-Wasting Syndrome

Status:
Completed

Trial end date:
1969-12-31

Target enrollment:

Participant gender:

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.

Phase:

Phase 1

Details

Lead Sponsor:

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborators:

Bristol-Myers Squibb
Roxane Laboratories

Treatments:

Dronabinol
Megestrol
Megestrol Acetate