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Nutrition Intervention in AIDS Wasting

Primary Purpose

HIV Wasting Syndrome

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
oxandrolone
Progressive Resistance Training
Sponsored by
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Wasting Syndrome focused on measuring oxandrolone, AIDS wasting, strength training, progressive resistance training, exercise, dietary intervention

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Tufts University School of Medicine

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
August 8, 2000
Last Updated
January 12, 2010
Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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1. Study Identification

Unique Protocol Identification Number
NCT00006167
Brief Title
Nutrition Intervention in AIDS Wasting
Study Type
Interventional

2. Study Status

Record Verification Date
January 2010
Overall Recruitment Status
Completed
Study Start Date
January 1998 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2000 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Wasting Syndrome
Keywords
oxandrolone, AIDS wasting, strength training, progressive resistance training, exercise, dietary intervention

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Masking
Double

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
oxandrolone
Intervention Type
Behavioral
Intervention Name(s)
Progressive Resistance Training

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sherwood Gorbach, MD
Organizational Affiliation
Tufts University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Abby Shevitz, MD
Organizational Affiliation
Tufts University
Official's Role
Study Director
Facility Information:
Facility Name
Tufts University School of Medicine
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States

12. IPD Sharing Statement

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Nutrition Intervention in AIDS Wasting

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