Completed

Evaluation of High Protein Supplementation in HIV-1-Positive Subjects With Stable Weight Loss

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Data Collection

Who is being recruted

Blood-Borne Infections+16

+ Urogenital Diseases

+ Genital Diseases

Over 18 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: May 1999
See protocol details

Summary

Principal SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: May 1, 1999

Actual date on which the first participant was enrolled.

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 protein rather than total caloric intake. Dietary sources of protein are presumably inadequate to meet the high metabolic needs caused by HIV infection. To achieve a target protein intake in the range (1.5 to 2.0 g/kg/day) demonstrated in other catabolic diseases necessary to achieve positive nitrogen balance and to generate substantial anabolic effects, this study will administer a supplement containing high-quality protein. Two groups of 28 patients each are randomly chosen to receive either an oral nutritional supplement (Optimune) containing increased amounts of high-quality protein (whey), which is rich in cysteine and glutamine, or an isocaloric, identical-tasting supplement without added whey protein or amino acid supplementation. Weight, body composition, anthropometry, dietary intake, and general physical health are assessed at baseline and at Weeks 6 and 12. Plasma cysteine, glutathione, C-reactive protein, and prealbumin, along with urine IL-6, sTNFrII, and IL-1ra, are assessed at baseline and at Week 12.

Official TitleEvaluation of High Protein Supplementation in HIV-1-Positive Subjects With Stable Weight Loss
NCT00000925
Principal SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

56 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.


Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Blood-Borne InfectionsUrogenital DiseasesGenital DiseasesCommunicable DiseasesImmunologic Deficiency SyndromesImmune System DiseasesInfectionsMetabolic DiseasesNutrition DisordersNutritional and Metabolic DiseasesRetroviridae InfectionsRNA Virus InfectionsSexually Transmitted DiseasesVirus DiseasesSexually Transmitted Diseases, ViralHIV InfectionsLentivirus InfectionsHIV Wasting SyndromeWasting Syndrome

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.

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 19 locations

Suspended

Univ of Southern California / LA County USC Med Ctr

Los Angeles, United StatesOpen Univ of Southern California / LA County USC Med Ctr in Google Maps
Suspended

UCLA CARE Ctr

Los Angeles, United States
Suspended

San Francisco Gen Hosp

San Francisco, United States
Suspended

Stanford Univ Med Ctr

Stanford, United States
Completed19 Study Centers