NCT00000925

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 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.

Trial Health

85
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for phase_2 hiv-infections

Geographic Reach
2 countries

19 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 1999

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

November 2, 1999

Completed
1.8 years until next milestone

First Posted

Study publicly available on registry

August 31, 2001

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2003

Completed
Last Updated

July 29, 2013

Status Verified

July 1, 2013

Enrollment Period

4.1 years

First QC Date

November 2, 1999

Last Update Submit

July 26, 2013

Conditions

HIV InfectionsHIV Wasting Syndrome

Keywords

Dietary ProteinsHIV Wasting Syndrome

Interventions

Optimune oral nutritional supplementDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (19)

Univ of Southern California / LA County USC Med Ctr

Los Angeles, California, 900331079, United States

Location

UCLA CARE Ctr

Los Angeles, California, 90095, United States

Location

San Francisco Gen Hosp

San Francisco, California, 941102859, United States

Location

Stanford Univ Med Ctr

Stanford, California, 943055107, United States

Location

Univ of Colorado Health Sciences Ctr

Denver, Colorado, 80262, United States

Location

Queens Med Ctr

Honolulu, Hawaii, 96816, United States

Location

Univ of Hawaii

Honolulu, Hawaii, 96816, United States

Location

Tulane Univ School of Medicine

New Orleans, Louisiana, 70112, United States

Location

Johns Hopkins Hosp

Baltimore, Maryland, 21287, United States

Location

St Louis Regional Hosp / St Louis Regional Med Ctr

St Louis, Missouri, 63112, United States

Location

Chelsea Ctr

New York, New York, 10021, United States

Location

Cornell Univ Med Ctr

New York, New York, 10021, United States

Location

Univ of Rochester Medical Center

Rochester, New York, 14642, United States

Location

Univ of Cincinnati

Cincinnati, Ohio, 452670405, United States

Location

Ohio State Univ Hosp Clinic

Columbus, Ohio, 432101228, United States

Location

Philadelphia Veterans Administration Med Ctr

Philadelphia, Pennsylvania, 19104, United States

Location

Julio Arroyo

West Columbia, South Carolina, 29169, United States

Location

Univ of Washington

Seattle, Washington, 98104, United States

Location

Univ of Puerto Rico

San Juan, 009365067, Puerto Rico

Location

MeSH Terms

Conditions

HIV InfectionsHIV Wasting Syndrome

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesWasting SyndromeMetabolic DiseasesNutritional and Metabolic DiseasesNutrition Disorders

Study Officials

  • Kathleen Mulligan, MD

    STUDY CHAIR

  • Bruce R. Bistrian, MD

    STUDY CHAIR

  • Fred R. Sattler, MD

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 2, 1999

First Posted

August 31, 2001

Study Start

May 1, 1999

Primary Completion

June 1, 2003

Last Updated

July 29, 2013

Record last verified: 2013-07

Locations

US(18)PR(1)