Nutrition Intervention in AIDS Wasting
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ClinicalTrials.gov Identifier: NCT00006167 |
Recruitment Status
:
Completed
First Posted
: August 9, 2000
Last Update Posted
: January 13, 2010
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV Wasting Syndrome | Drug: oxandrolone Behavioral: Progressive Resistance Training | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Masking: | Double |
Primary Purpose: | Treatment |
Study Start Date : | January 1998 |
Study Completion Date : | August 2000 |


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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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).

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00006167
United States, Massachusetts | |
Tufts University School of Medicine | |
Boston, Massachusetts, United States, 02111 |
Principal Investigator: | Sherwood Gorbach, MD | Tufts University | |
Study Director: | Abby Shevitz, MD | Tufts University |
ClinicalTrials.gov Identifier: | NCT00006167 History of Changes |
Other Study ID Numbers: |
NIAW (completed) DK51011 |
First Posted: | August 9, 2000 Key Record Dates |
Last Update Posted: | January 13, 2010 |
Last Verified: | January 2010 |
Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):
oxandrolone AIDS wasting strength training |
progressive resistance training exercise dietary intervention |
Additional relevant MeSH terms:
Cachexia Wasting Syndrome HIV Wasting Syndrome Emaciation Weight Loss Body Weight Changes Body Weight Signs and Symptoms Metabolic Diseases Nutrition Disorders HIV Infections Lentivirus Infections Retroviridae Infections |
RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Oxandrolone Androgens Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Anabolic Agents |