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| Sponsor: | National Center for Research Resources (NCRR) |
|---|---|
| Collaborator: |
Northwestern University |
| Information provided by: | Office of Rare Diseases (ORD) |
| ClinicalTrials.gov Identifier: | NCT00004664 |
Purpose
OBJECTIVES: I. Evaluate the effect of aerobic exercise and progressive resistance plus megestrol acetate on lean body mass of patients with human immunodeficiency virus-related weight loss (HIV-wasting).
II. Evaluate whether exercise acutely alters immune function. III. Evaluate whether long-term exercise improves immunocompetence. IV. Evaluate the accuracy of multifrequency bioelectrical impedance spectral analysis in measuring body composition.
V. Assess the impact of these therapies on quality of life. VI. Evaluate the effect of these therapies on the balance of energy intake and energy expenditure.
| Condition | Intervention |
|---|---|
|
Acquired Immunodeficiency Syndrome HIV Wasting Syndrome HIV Infections |
Drug: megestrol Behavioral: Exercise |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Primary Purpose: Treatment |
| Estimated Enrollment: | 69 |
| Study Start Date: | June 1995 |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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:
Contacts and Locations More Information
| ClinicalTrials.gov Identifier: | NCT00004664 History of Changes |
| Other Study ID Numbers: | 199/11931, NU-516 |
| Study First Received: | February 24, 2000 |
| Last Updated: | June 23, 2005 |
| Health Authority: | United States: Federal Government |
|
disease-related problem/condition human immunodeficiency virus infection immunologic disorders and infectious disorders |
nutrition rare disease viral infection |
|
HIV Infections Acquired Immunodeficiency Syndrome Immunologic Deficiency Syndromes Wasting Syndrome HIV Wasting Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immune System Diseases Slow Virus Diseases Metabolic Diseases Nutrition Disorders |
Megestrol Acetate Megestrol Antineoplastic Agents, Hormonal Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Appetite Stimulants Central Nervous System Stimulants Physiological Effects of Drugs Central Nervous System Agents Contraceptives, Oral, Synthetic Contraceptives, Oral Contraceptive Agents, Female Contraceptive Agents Reproductive Control Agents |
