Search / Trial NCT00000925

A Study to Evaluate High Protein Supplementation in HIV-Positive Patients With Stable Weight Loss

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001

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Trial Information

Current as of May 23, 2024

Completed

Keywords

Dietary Proteins Hiv Wasting Syndrome

Description

In many HIV-infected individuals with prior weight loss, the failure to regain weight and lean tissue is at least in part the consequence of inadequate protein intake or ingestion of a poor-quality protein rather than total caloric intake. Dietary sources of protein are presumably inadequate to meet the high metabolic needs caused by HIV infection. To achieve a target protein intake in the range (1.5 to 2.0 g/kg/day) demonstrated in other catabolic diseases necessary to achieve positive nitrogen balance and to generate substantial anabolic effects, this study will administer a supplement co...

Gender

All

Eligibility criteria

  • Inclusion Criteria
  • You may be eligible for this study if you:
  • Are HIV-positive.
  • Are at least 18 years old.
  • Have an HIV level less than 5,000 copies/ml within 30 days of study entry.
  • Have lost weight in the past year, but your weight has remained fairly stable in the 2 months prior to enrollment.
  • Are expected to live for at least 6 months.
  • Are usually able to eat enough to maintain your present weight.
  • Are able to complete a 3-day food diary.
  • Exclusion Criteria
  • You will not be eligible for this study if you:
  • Have gained a significant amount of weight in the past 2 months.
  • Have any opportunistic (HIV-associated) infections.
  • Are unable to eat enough food for any reason, or are on tube feeding.
  • Have nausea, diarrhea, or vomiting in the 14 days prior to study entry.
  • Are being treated for diabetes.
  • Are receiving chemotherapy or radiation therapy to treat cancer.
  • Are pregnant or breast-feeding.
  • Are allergic to milk or mangoes.
  • Have an implanted defibrillator.

Attachments

readout_NCT00000925_2024-05-23.pdf

4.5 MB

NCT00000925_study_protocol.pdf

4.5 MB

About company

The National Institute of Allergy and Infectious Diseases (NIAID, /ˈnaɪ.æd/) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services (HHS). NIAID's mission is to conduct basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases.

Contacts

JC

Jennifer Cobb

Immunology at National Institute of Allergy and Infectious Diseases (NIAID)

Locations

Los Angeles, California, United States

New York, New York, United States

Columbus, Ohio, United States

West Columbia, South Carolina, United States

San Francisco, California, United States

Seattle, Washington, United States

Rochester, New York, United States

Stanford, California, United States

Honolulu, Hawaii, United States

Honolulu, Hawaii, United States

Baltimore, Maryland, United States

Cincinnati, Ohio, United States

San Juan, , Puerto Rico

Los Angeles, California, United States

New Orleans, Louisiana, United States

Denver, Colorado, United States

St Louis, Missouri, United States

New York, New York, United States

Philadelphia, Pennsylvania, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Reviews (48)

4.6

All reviews come from applied patients

5 stars
41
4 stars
6
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1 stars
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Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Michael Foster
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Dries Vincent
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

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