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Home > "N" Clinical Trials Conditions > Nutrition Intervention in AIDS Wasting  Nutrition Intervention in AIDS Wasting
Nutrition Intervention in AIDS Wasting
For Condition: HIV Wasting Syndrome
Status: Completed
Sponsor(s): National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) ,
Synopsis: There are no guidelines for appropriate nutritional management of weight loss or wasting in HIV infection. Some treatments may increase weight, but without improving muscle mass or quality of life. In this clinical trial AIDS patients with wasting are randomized to one of three nutritional strategies and studied over a 12-week period: 1) optimal oral nutrition with counseling and protein and calorie supplementation, and a placebo pill; 2) optimal oral nutrition with the oral androgen, oxandrolone at 20 mg daily; and 3) optimal oral nutrition with progressive resistance training (PRT). In all participants, dietary intervention is maximized by weekly personalized counseling to address individual issues and concerns. Two primary outcomes are assessed: thigh muscle mass and quality of life. Our findings can be used to develop guidelines for standards of nutritional care among AIDS patient with the wasting syndrome.
Details:
Eligibility:
Study Type: Interventional, Treatment, Double-Blind
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria: - Loss of 10% of usual body weight, OR loss of 5% of usual body weight within the previous 6 months, OR BMI20kg/m2. If the candidate is taking a protease inhibitor, he/she must have not regained weight since initiating the medication over a period of at least 4 weeks prior to screening. - Documented HIV-positive - Able to eat - English-speaking - Compliance with medical regimens - For heterosexually active women: willingness to use an effective means of birth control - Patient and physician not planning to start new treatments for HIV infection or weight loss during the 12 weeks of study. Exclusion Criteria: - Vomiting 1 time/day or diarrhea 4 times/day on average in the previous week - Fever 101 F within the previous week - Receiving induction treatment for one of the following (new diagnosis or recurrence within 4 weeks): Pneumocystis carinii pneumonia Cryptococcal meningitis Cytomegalovirus retinitis or pneumonitis Toxoplasmosis Mycobacterium avium complex Visceral Kaposi's Sarcoma Lymphoma Pulmonary tuberculosis - Received corticosteroids, estrogens, progesterones, androgens, oral anticoagulants, or growth hormone within the previous three months - History of life-threatening reaction to oxandrolone or testosterone - Currently pregnant - History of congestive heart failure, myocardial infarction, angina/coronary artery disease, uncontrolled hypertension, cerebrovascular accident, hepatic failure, bleeding disorder, diabetes, nephrotic syndrome, cancer of the breast or prostate, or hypercalcemia - Milk product allergy - Current use of injected drugs - Participation in an exercise program or strength training within the previous 4 weeks - Any medical condition which renders the participant physically incapable of performing strength exercises - Serum total testosterone level at least 300ng/ml, unless patient and primary physician prepared to begin testosterone injections concurrent with study enrollment (men only).
Total Enrollment:
Location and Contact Information:
Overall Study Official:
SherwoodGorbach, Principal Investigator, Tufts University
Tufts University School of Medicine
Boston, Massachusetts, 02111
United States
Additional Information:
Study ID Numbers: NIAW; DK51011
Study Start Date: January 1998
Record last reviewed: May 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00006167
Other Hiv Wasting Syndrome Studies:
1. The Effect of Anti-HIV Treatment on Body Characteristics of HIV-Infected Children
2. Randomized Placebo-Controlled Study of Aerobic Exercise and Resistance Training Plus Megestrol Acetate for HIV-Wasting
3. Nutrition Intervention in AIDS Wasting
4. A Comparison of Two Caloric Supplements in the Prevention of Weight Loss in Patients with AIDS Who Take Daily Multivitamin and Mineral Supplements
5. A Phase I/II Study to Evaluate Single Agent and Combination Therapy With Megestrol Acetate and Dronabinol for the Treatment of HIV-Wasting Syndrome
Related Studies:
Other HIV Wasting Syndrome Clinical Trials
Other Massachusetts Clinical Trials
Other Boston Clinical Trials
Nutrition Intervention in AIDS Wasting
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