Status:
COMPLETED
A Study to Evaluate High Protein Supplementation in HIV-Positive Patients With Stable Weight Loss
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
HIV Infections
HIV Wasting Syndrome
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 weig...
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 pr...
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.
Key Trial Info
Start Date :
May 1 1999
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT00000925
Start Date
May 1 1999
Last Update
July 29 2013
Active Locations (19)
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1
Univ of Southern California / LA County USC Med Ctr
Los Angeles, California, United States, 900331079
2
UCLA CARE Ctr
Los Angeles, California, United States, 90095
3
San Francisco Gen Hosp
San Francisco, California, United States, 941102859
4
Stanford Univ Med Ctr
Stanford, California, United States, 943055107