Nutrition Intervention in AIDS Wasting

HIV Wasting Syndrome Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00006167
• Other study ID #: NIAW (completed)
• Secondary ID: DK51011
• Status: Completed
• Phase: Phase 4
• First received: August 8, 2000
• Last updated: January 12, 2010
• Start date: January 1998
• Est. completion date: August 2000

Study information

• Verified date: January 2010
• Source: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: August 2000
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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).

Study Design

Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cachexia
• HIV Wasting Syndrome

Intervention

Drug:
• oxandrolone

Behavioral:
• Progressive Resistance Training

Locations

Country	Name	City	State
United States	Tufts University School of Medicine	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States,