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

Completed · Phase 2

Conditions studied: HIV Infections, HIV Wasting Syndrome

In brief

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.

Key facts

Study ID

NCT00000925

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

56

Starts

1999-05-01

Last updated by the study team

2013-07-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Univ of Southern California / LA County USC Med Ctr — Los Angeles, California, United States
• UCLA CARE Ctr — Los Angeles, California, United States
• San Francisco Gen Hosp — San Francisco, California, United States
• Stanford Univ Med Ctr — Stanford, California, United States
• Univ of Colorado Health Sciences Ctr — Denver, Colorado, United States
• Queens Med Ctr — Honolulu, Hawaii, United States
• Univ of Hawaii — Honolulu, Hawaii, United States
• Tulane Univ School of Medicine — New Orleans, Louisiana, United States
• Johns Hopkins Hosp — Baltimore, Maryland, United States
• St Louis Regional Hosp / St Louis Regional Med Ctr — St Louis, Missouri, United States
• Chelsea Ctr — New York, New York, United States
• Cornell Univ Med Ctr — New York, New York, United States
• Univ of Rochester Medical Center — Rochester, New York, United States
• Univ of Cincinnati — Cincinnati, Ohio, United States
• Ohio State Univ Hosp Clinic — Columbus, Ohio, United States
• Philadelphia Veterans Administration Med Ctr — Philadelphia, Pennsylvania, United States
• Julio Arroyo — West Columbia, South Carolina, United States
• Univ of Washington — Seattle, Washington, United States
• Univ of Puerto Rico — San Juan, Puerto Rico

Full record on ClinicalTrials.gov

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