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CompletedNCT00006167Updated Jan 13, 2010

Nutrition Intervention in AIDS Wasting

A Phase 4 interventional study of oxandrolone and Progressive Resistance Training in HIV Wasting Syndrome, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2010-01-13.

Sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Ages
18 Years and older
Sex
All
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Study summary

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.

02

Conditions studied

  • HIV Wasting Syndrome

Keywords

  • oxandrolone
  • AIDS wasting
  • strength training
  • progressive resistance training
  • exercise
  • dietary intervention
03

In context

Wasting Syndrome

196 studies on the registry are indexed under Wasting Syndrome; 22 are open to participants now.

Browse Wasting Syndrome studies →

Lead sponsor

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) is the lead sponsor of 529 studies on the registry; 54 are open to participants now.

Of its 79 completed or terminated interventional studies of FDA-regulated products, 50 (63%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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).
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Study design

Phase
Phase 4
Primary purpose
Treatment
Masking
Double

Interventions

  • Drugoxandrolone
  • BehavioralProgressive Resistance Training
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Study locations

1 site
  • Tufts University School of Medicine
    Boston, Massachusetts 02111, United States
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 13, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00006167
Lead sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted
Aug 9, 2000
Start date
Jan 1998
Completion
Aug 2000
Last update
Jan 13, 2010

Study contacts

Sherwood Gorbach, MD
principal investigator · Tufts University
Abby Shevitz, MD
study director · Tufts University
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2010. You cannot join it, but the record below documents what was studied.

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