Clinical trialNCT00000925CompletedPhase 2Interventional

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

SponsorNational Institute of Allergy and Infectious Diseases (NIAID)Enrollment56HIV InfectionsHIV Wasting Syndrome

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

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Investigators

The overall officials registered on this study. Names that resolve to a FindMyKOL profile link to it; the rest are shown as registered.

Bruce R. Bistrian, MD
Study Chair
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Fred R. Sattler, MD
Study Chair
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Kathleen Mulligan, MD
Study Chair
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A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

19 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

Puerto Rico

Univ of Puerto Rico
San Juan, Puerto Rico

United States

Ucla Care Ctr
Los Angeles, California, United States
Univ of Southern California / la County Usc Med 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

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Optimune oral nutritional supplement

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 31 May 1999
Primary completion: 30 Jun 2003
Completion: —
Last update posted: 29 Jul 2013
Registered enrollment: 56
Registry id: NCT00000925

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 4 Nov 2026. Registry facts are shown as registered by the study sponsor; FindMyKOL does not interpret them.