A Study of Megestrol Acetate Alone or in Combination With Testosterone Enanthate Drug in the Treatment of HIV-Associated Weight Loss
Completed
National Institute of Allergy and Infectious Diseases (NIAID)
Phase 2
1969-12-31
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.
Phase II Study of Leuprolide and Testosterone for Men With Kennedy's Disease or Other Motor Neuron Disease
Completed
Ohio State University
Phase 2
1992-10-01
OBJECTIVES:
I. Evaluate the effects of androgen suppression with leuprolide and androgen replacement with
testosterone enanthate on muscle strength in men with Kennedy's disease or other motor neuron
disease.
Phase II Study of Leuprolide and Testosterone for Men With Kennedy's Disease or Other Motor Neuron Disease
Completed
National Center for Research Resources (NCRR)
Phase 2
1992-10-01
OBJECTIVES:
I. Evaluate the effects of androgen suppression with leuprolide and androgen replacement with
testosterone enanthate on muscle strength in men with Kennedy's disease or other motor neuron
disease.
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