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

This study has been completed.

Sponsors and Collaborators: National Center for Research Resources (NCRR)
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

MedlinePlus related topics:   AIDS    Exercise and Physical Fitness   

ChemIDplus related topics:   Megestrol acetate    Megestrol   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Placebo Control

Further study details as provided by Office of Rare Diseases (ORD):

Estimated Enrollment:   69
Study Start Date:   June 1995

Detailed Description:

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

Criteria

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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004664

Sponsors and Collaborators

Investigators
Study Chair:     Jamie Hayden Von Roenn     Northwestern University    
  More Information

Study ID Numbers:   199/11931, NU-516
First Received:   February 24, 2000
Last Updated:   June 23, 2005
ClinicalTrials.gov Identifier:   NCT00004664
Health Authority:   United States: Federal Government

Keywords provided by Office of Rare Diseases (ORD):
disease-related problem/condition  
human immunodeficiency virus infection  
immunologic disorders and infectious disorders  
nutrition
rare disease
viral infection

Study placed in the following topic categories:
Sexually Transmitted Diseases, Viral
Metabolic Diseases
HIV Wasting Syndrome
Acquired Immunodeficiency Syndrome
Rare Diseases
Megestrol
Immunologic Deficiency Syndromes
Virus Diseases
HIV Infections
Sexually Transmitted Diseases
Nutrition Disorders
Wasting Syndrome
Metabolic disorder
Retroviridae Infections
Megestrol Acetate

Additional relevant MeSH terms:
RNA Virus Infections
Slow Virus Diseases
Disease
Immune System Diseases
Antineoplastic Agents, Hormonal
Contraceptive Agents
Antineoplastic Agents
Physiological Effects of Drugs
Contraceptives, Oral
Contraceptive Agents, Female
Central Nervous System Stimulants
Reproductive Control Agents
Infection
Pharmacologic Actions
Pathologic Processes
Syndrome
Therapeutic Uses
Lentivirus Infections
Contraceptives, Oral, Synthetic
Central Nervous System Agents
Appetite Stimulants

ClinicalTrials.gov processed this record on September 05, 2008




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