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

Primary Purpose

HIV Infections, HIV Wasting Syndrome

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Optimune oral nutritional supplement
Sponsored by
National Institute of Allergy and Infectious Diseases (NIAID)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring Dietary Proteins, HIV Wasting Syndrome

Eligibility Criteria

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

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.

Sites / Locations

  • Univ of Southern California / LA County USC Med Ctr
  • UCLA CARE Ctr
  • San Francisco Gen Hosp
  • Stanford Univ Med Ctr
  • Univ of Colorado Health Sciences Ctr
  • Queens Med Ctr
  • Univ of Hawaii
  • Tulane Univ School of Medicine
  • Johns Hopkins Hosp
  • St Louis Regional Hosp / St Louis Regional Med Ctr
  • Chelsea Ctr
  • Cornell Univ Med Ctr
  • Univ of Rochester Medical Center
  • Univ of Cincinnati
  • Ohio State Univ Hosp Clinic
  • Philadelphia Veterans Administration Med Ctr
  • Julio Arroyo
  • Univ of Washington
  • Univ of Puerto Rico

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
July 26, 2013
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
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1. Study Identification

Unique Protocol Identification Number
NCT00000925
Brief Title
A Study to Evaluate High Protein Supplementation in HIV-Positive Patients With Stable Weight Loss
Official Title
Evaluation of High Protein Supplementation in HIV-1-Positive Subjects With Stable Weight Loss
Study Type
Interventional

2. Study Status

Record Verification Date
July 2013
Overall Recruitment Status
Completed
Study Start Date
May 1999 (undefined)
Primary Completion Date
June 2003 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)

4. Oversight

5. Study Description

Brief Summary
The purpose of this study is to determine whether a high-quality protein food supplement will help HIV-positive patients maintain, and possibly gain, muscle mass. Many HIV-positive patients lose weight that they are then unable to regain. This may be because patients are not eating enough protein or are not eating the right kinds of protein. The protein eaten in foods (such as meat, eggs, or beans) may not be able to make up for the amount of protein lost due to HIV infection. This study gives patients high-quality protein food supplements to help them maintain and/or gain weight.
Detailed 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 containing high-quality protein. Two groups of 28 patients each are randomly chosen to receive either an oral nutritional supplement (Optimune) containing increased amounts of high-quality protein (whey), which is rich in cysteine and glutamine, or an isocaloric, identical-tasting supplement without added whey protein or amino acid supplementation. Weight, body composition, anthropometry, dietary intake, and general physical health are assessed at baseline and at Weeks 6 and 12. Plasma cysteine, glutathione, C-reactive protein, and prealbumin, along with urine IL-6, sTNFrII, and IL-1ra, are assessed at baseline and at Week 12.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections, HIV Wasting Syndrome
Keywords
Dietary Proteins, HIV Wasting Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
56 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Optimune oral nutritional supplement

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kathleen Mulligan, MD
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Bruce R. Bistrian, MD
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Fred R. Sattler, MD
Official's Role
Study Chair
Facility Information:
Facility Name
Univ of Southern California / LA County USC Med Ctr
City
Los Angeles
State/Province
California
ZIP/Postal Code
900331079
Country
United States
Facility Name
UCLA CARE Ctr
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
San Francisco Gen Hosp
City
San Francisco
State/Province
California
ZIP/Postal Code
941102859
Country
United States
Facility Name
Stanford Univ Med Ctr
City
Stanford
State/Province
California
ZIP/Postal Code
943055107
Country
United States
Facility Name
Univ of Colorado Health Sciences Ctr
City
Denver
State/Province
Colorado
ZIP/Postal Code
80262
Country
United States
Facility Name
Queens Med Ctr
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96816
Country
United States
Facility Name
Univ of Hawaii
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96816
Country
United States
Facility Name
Tulane Univ School of Medicine
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Johns Hopkins Hosp
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
St Louis Regional Hosp / St Louis Regional Med Ctr
City
St Louis
State/Province
Missouri
ZIP/Postal Code
63112
Country
United States
Facility Name
Chelsea Ctr
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Cornell Univ Med Ctr
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Univ of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
Univ of Cincinnati
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
452670405
Country
United States
Facility Name
Ohio State Univ Hosp Clinic
City
Columbus
State/Province
Ohio
ZIP/Postal Code
432101228
Country
United States
Facility Name
Philadelphia Veterans Administration Med Ctr
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Julio Arroyo
City
West Columbia
State/Province
South Carolina
ZIP/Postal Code
29169
Country
United States
Facility Name
Univ of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
Univ of Puerto Rico
City
San Juan
ZIP/Postal Code
009365067
Country
Puerto Rico

12. IPD Sharing Statement

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

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