Nutrition Intervention in AIDS Wasting

This study has been completed.
Sponsor:
Information provided by:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:
NCT00006167
First received: August 8, 2000
Last updated: January 12, 2010
Last verified: January 2010
  Purpose

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.


Condition Intervention Phase
HIV Wasting Syndrome
Drug: oxandrolone
Behavioral: Progressive Resistance Training
Phase 4

Study Type: Interventional
Study Design: Masking: Double-Blind
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

Study Start Date: January 1998
Estimated Study Completion Date: August 2000
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00006167

Locations
United States, Massachusetts
Tufts University School of Medicine
Boston, Massachusetts, United States, 02111
Sponsors and Collaborators
Investigators
Principal Investigator: Sherwood Gorbach, MD Tufts University
Study Director: Abby Shevitz, MD Tufts University
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00006167     History of Changes
Other Study ID Numbers: NIAW (completed), DK51011
Study First Received: August 8, 2000
Last Updated: January 12, 2010
Health Authority: United States: Federal Government

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
Pharmacologic Actions
Anabolic Agents

ClinicalTrials.gov processed this record on August 27, 2014