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Nutrition Intervention in AIDS Wasting

NCT00006167 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2010-01-13

No results posted yet for this 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.

Conditions

  • HIV Wasting Syndrome

Interventions

DRUG

oxandrolone

BEHAVIORAL

Progressive Resistance Training

Sponsors & Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    lead NIH

Principal Investigators

  • Sherwood Gorbach, MD · Tufts University

  • Abby Shevitz, MD · Tufts University

Study Design

Purpose
TREATMENT
Masking
DOUBLE

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1998-01-31
Completion
2000-08-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00006167 on ClinicalTrials.gov