- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00006167
Nutrition Intervention in AIDS Wasting
January 12, 2010 updated by: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Massachusetts
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Boston, Massachusetts, United States, 02111
- Tufts University School of Medicine
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Masking: Double
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Sherwood Gorbach, MD, Tufts University
- Study Director: Abby Shevitz, MD, Tufts University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 1998
Study Completion
August 1, 2000
Study Registration Dates
First Submitted
August 8, 2000
First Submitted That Met QC Criteria
August 8, 2000
First Posted (Estimate)
August 9, 2000
Study Record Updates
Last Update Posted (Estimate)
January 13, 2010
Last Update Submitted That Met QC Criteria
January 12, 2010
Last Verified
January 1, 2010
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Metabolic Diseases
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immunologic Deficiency Syndromes
- Immune System Diseases
- Nutrition Disorders
- Body Weight
- Body Weight Changes
- HIV Infections
- Emaciation
- Weight Loss
- Wasting Syndrome
- Cachexia
- HIV Wasting Syndrome
- Physiological Effects of Drugs
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Androgens
- Anabolic Agents
- Oxandrolone
Other Study ID Numbers
- NIAW (completed)
- DK51011
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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