HIV Infections Clinical Trial
NCT number | NCT00004664 |
Other study ID # | 199/11931 |
Secondary ID | NU-516 |
Status | Completed |
Phase | N/A |
First received | February 24, 2000 |
Last updated | June 23, 2005 |
Start date | June 1995 |
Verified date | December 2001 |
Source | Office of Rare Diseases (ORD) |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Federal Government |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 69 |
Est. completion date | |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Randomized, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
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National Center for Research Resources (NCRR) | Northwestern University |
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