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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

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.