Randomized Placebo-Controlled Study of Aerobic Exercise and Resistance Training Plus Megestrol Acetate for HIV-Wasting

PROTOCOL OUTLINE: Patients are randomly assigned to 1 of 3 therapy groups: megestrol acetate alone, exercise plus megestrol acetate, or exercise plus placebo. Therapy continues for 12 weeks.

A single dose of oral megestrol acetate or placebo is administered each morning.

The exercise program consists of aerobic exercise and resistance training performed 3 times a week under supervision. Hard aerobic exercise is performed for 45 minutes plus a warm-up and cool-down period; the patient chooses to work on 3 of 5 pieces of exercise equipment. Exercise intensity is adjusted to a heart rate corresponding to 65% of maximal oxygen consumption.

Resistance training is done on a universal gym; exercises are designed to work all 6 major muscle groups. Each exercise is performed at 70% of maximal single repetition resistance. Resistance is increased 5% when the patient can perform 15 repetitions without failure.

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

Human immunodeficiency virus seropositive with acquired immune deficiency syndrome

Documented weight loss 5% to 15% below ideal weight

--Prior/Concurrent Therapy--

No concurrent appetite stimulants

At least 6 weeks since initiation of new antiretroviral therapy

--Patient Characteristics--

Performance status: Karnofsky 70%-100%

Hepatic: No ascites

Renal: No nephrosis

Other:

• No acute or untreated infection within 4 weeks prior to entry
• No hospitalization within 2 weeks prior to entry
• No gonadal insufficiency
• No edema
• No pleural effusion
• No uncontrolled diarrhea
• No physical or functional obstruction to food intake
• No physical handicap that would prevent resistance or aerobic exercise
• No cardiac abnormality that would render aerobic exercise a health risk
• No concurrent regular exercise of 3 or more hours a week
• No mental incompetence