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

NCT00004664 | Completed

• 2 other identifiers: 199/11931NU-516
• Study Type: interventional
• Target: 69
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Acquired Immunodeficiency Syndrome; HIV Wasting Syndrome; HIV Infections

Keywords

disease-related problem/condition; human immunodeficiency virus infection; immunologic disorders and infectious disorders; nutrition; rare disease; viral infection

Interventions

megestrol DRUG

Exercise BEHAVIORAL

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Center for Research Resources (NCRR): lead
• Northwestern University: collaborator

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; HIV Wasting Syndrome; HIV Infections; Immune System Diseases; Communicable Diseases; Rare Diseases; Virus Diseases

Interventions

Megestrol; Exercise

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Wasting Syndrome; Metabolic Diseases; Nutritional and Metabolic Diseases; Nutrition Disorders; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Jamie Hayden Von Roenn

  Northwestern University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Sponsor Type: NIH

Study Record Dates

• First Submitted: February 24, 2000
• First Posted: February 25, 2000
• Study Start: June 1, 1995
• Last Updated: June 24, 2005

Record last verified: 2001-12