Completed
Evaluation of High Protein Supplementation in HIV-1-Positive Subjects With Stable Weight Loss
Led by National Institute of Allergy and Infectious Diseases (NIAID) · Updated on 2013-07-29
56
Participants Needed
19
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study to Evaluate High Protein Supplementation in HIV-Positive Patients With Stable Weight Loss
Who Can Participate
Eligibility Criteria
You may qualify if you...
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.
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
Trial Site Locations
Total: 19 locations
1
Univ of Southern California / LA County USC Med Ctr
Los Angeles, California, United States, 900331079
Status Unknown
2
UCLA CARE Ctr
Los Angeles, California, United States, 90095
Status Unknown
3
San Francisco Gen Hosp
San Francisco, California, United States, 941102859
Status Unknown
4
Stanford Univ Med Ctr
Stanford, California, United States, 943055107
Status Unknown
5
Univ of Colorado Health Sciences Ctr
Denver, Colorado, United States, 80262
Status Unknown
6
Queens Med Ctr
Honolulu, Hawaii, United States, 96816
Status Unknown
7
Univ of Hawaii
Honolulu, Hawaii, United States, 96816
Status Unknown
8
Tulane Univ School of Medicine
New Orleans, Louisiana, United States, 70112
Status Unknown
9
Johns Hopkins Hosp
Baltimore, Maryland, United States, 21287
Status Unknown
10
St Louis Regional Hosp / St Louis Regional Med Ctr
St Louis, Missouri, United States, 63112
Status Unknown
11
Chelsea Ctr
New York, New York, United States, 10021
Status Unknown
12
Cornell Univ Med Ctr
New York, New York, United States, 10021
Status Unknown
13
Univ of Rochester Medical Center
Rochester, New York, United States, 14642
Status Unknown
14
Univ of Cincinnati
Cincinnati, Ohio, United States, 452670405
Status Unknown
15
Ohio State Univ Hosp Clinic
Columbus, Ohio, United States, 432101228
Status Unknown
16
Philadelphia Veterans Administration Med Ctr
Philadelphia, Pennsylvania, United States, 19104
Status Unknown
17
Julio Arroyo
West Columbia, South Carolina, United States, 29169
Status Unknown
18
Univ of Washington
Seattle, Washington, United States, 98104
Status Unknown
19
Univ of Puerto Rico
San Juan, Puerto Rico, 009365067
Status Unknown
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
0
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