Nutrition Intervention in AIDS Wasting

NCT ID: NCT00006167

Last Updated: 2010-01-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Study Classification: INTERVENTIONAL
• Study Start Date: 1998-01-31
• Study Completion Date: 2000-08-31

Brief 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

Study Design

• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

oxandrolone

Intervention Type: DRUG

Progressive Resistance Training

Intervention Type: BEHAVIORAL

Eligibility 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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

NIH

Sponsor Role: lead

Principal Investigators

Sherwood Gorbach, MD

Role: PRINCIPAL_INVESTIGATOR

Tufts University

Abby Shevitz, MD

Role: STUDY_DIRECTOR

Tufts University

Locations

Tufts University School of Medicine

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

DK51011

Identifier Type: -

Identifier Source: secondary_id

NIAW (completed)

Identifier Type: -

Identifier Source: org_study_id