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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00000925
First received: November 2, 1999
Last updated: July 26, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention Phase
HIV Infections
HIV Wasting Syndrome
Drug: Optimune oral nutritional supplement
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Evaluation of High Protein Supplementation in HIV-1-Positive Subjects With Stable Weight Loss

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Estimated Enrollment: 56
Study Start Date: May 1999
Primary Completion Date: June 2003 (Final data collection date for primary outcome measure)
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00000925

Locations
United States, California
UCLA CARE Ctr
Los Angeles, California, United States, 90095
Univ of Southern California / LA County USC Med Ctr
Los Angeles, California, United States, 900331079
San Francisco Gen Hosp
San Francisco, California, United States, 941102859
Stanford Univ Med Ctr
Stanford, California, United States, 943055107
United States, Colorado
Univ of Colorado Health Sciences Ctr
Denver, Colorado, United States, 80262
United States, Hawaii
Univ of Hawaii
Honolulu, Hawaii, United States, 96816
Queens Med Ctr
Honolulu, Hawaii, United States, 96816
United States, Louisiana
Tulane Univ School of Medicine
New Orleans, Louisiana, United States, 70112
United States, Maryland
Johns Hopkins Hosp
Baltimore, Maryland, United States, 21287
United States, Missouri
St Louis Regional Hosp / St Louis Regional Med Ctr
St Louis, Missouri, United States, 63112
United States, New York
Chelsea Ctr
New York, New York, United States, 10021
Cornell Univ Med Ctr
New York, New York, United States, 10021
Univ of Rochester Medical Center
Rochester, New York, United States, 14642
United States, Ohio
Univ of Cincinnati
Cincinnati, Ohio, United States, 452670405
Ohio State Univ Hosp Clinic
Columbus, Ohio, United States, 432101228
United States, Pennsylvania
Philadelphia Veterans Administration Med Ctr
Philadelphia, Pennsylvania, United States, 19104
United States, South Carolina
Julio Arroyo
West Columbia, South Carolina, United States, 29169
United States, Washington
Univ of Washington
Seattle, Washington, United States, 98104
Puerto Rico
Univ of Puerto Rico
San Juan, Puerto Rico, 009365067
Sponsors and Collaborators
Investigators
Study Chair: Kathleen Mulligan, MD
Study Chair: Bruce R. Bistrian, MD
Study Chair: Fred R. Sattler, MD
  More Information

Additional Information:
No publications provided

Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00000925     History of Changes
Other Study ID Numbers: ACTG 392, 11349
Study First Received: November 2, 1999
Last Updated: July 26, 2013
Health Authority: United States: Federal Government

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Dietary Proteins
HIV Wasting Syndrome

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
HIV Wasting Syndrome
Syndrome
Wasting Syndrome
Weight Loss
Body Weight
Body Weight Changes
Disease
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
Metabolic Diseases
Nutrition Disorders
Pathologic Processes
Retroviridae Infections
RNA Virus Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Signs and Symptoms
Slow Virus Diseases
Virus Diseases

ClinicalTrials.gov processed this record on October 21, 2014