Nutrition Intervention in AIDS Wasting

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00006167
Recruitment Status : Completed
First Posted : August 9, 2000
Last Update Posted : January 13, 2010
Information provided by:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

August 8, 2000
August 9, 2000
January 13, 2010
January 1998
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Complete list of historical versions of study NCT00006167 on Archive Site
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Nutrition Intervention in AIDS Wasting
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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.
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Phase 4
Masking: Double
Primary Purpose: Treatment
HIV Wasting Syndrome
  • Drug: oxandrolone
  • Behavioral: Progressive Resistance Training
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
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August 2000
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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).
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
United States
NIAW (completed)
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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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Principal Investigator: Sherwood Gorbach, MD Tufts University
Study Director: Abby Shevitz, MD Tufts University
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
January 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP