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

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

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.

Study Overview

• Status: Completed
• Conditions: HIV Infections; HIV Wasting Syndrome
• Intervention / Treatment: Drug: Optimune oral nutritional supplement

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.

• Study Type: Interventional
• Enrollment: 56
• Phase: Phase 2

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Collaborators and Investigators

• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Investigators: Study Chair: Kathleen Mulligan, MD; Study Chair: Bruce R. Bistrian, MD; Study Chair: Fred R. Sattler, MD

Study record dates

Study Major Dates

• Study Start: May 1, 1999
• Primary Completion (Actual): June 1, 2003

Study Registration Dates

• First Submitted: November 2, 1999
• First Submitted That Met QC Criteria: August 30, 2001
• First Posted (Estimate): August 31, 2001

Study Record Updates

• Last Update Posted (Estimate): July 29, 2013
• Last Update Submitted That Met QC Criteria: July 26, 2013
• Last Verified: July 1, 2013

More Information

Terms related to this study

• Keywords: HIV Wasting Syndrome; Dietary Proteins
• Additional Relevant MeSH Terms: Metabolic Diseases; RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; Nutrition Disorders; Body Weight; Body Weight Changes; HIV Infections; Emaciation; Weight Loss; Wasting Syndrome; Cachexia; HIV Wasting Syndrome
• Other Study ID Numbers: ACTG 392; 11349 (DAIDS-ES)