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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00000925
Recruitment Status : Completed
First Posted : August 31, 2001
Last Update Posted : July 29, 2013
Sponsor:
Information provided by (Responsible Party):

November 2, 1999
August 31, 2001
July 29, 2013
May 1999
June 2003   (Final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00000925 on ClinicalTrials.gov Archive Site
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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.

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.

Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
  • HIV Infections
  • HIV Wasting Syndrome
Drug: Optimune oral nutritional supplement
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
56
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June 2003   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Puerto Rico,   United States
 
 
NCT00000925
ACTG 392
11349 ( Registry Identifier: DAIDS-ES )
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National Institute of Allergy and Infectious Diseases (NIAID)
National Institute of Allergy and Infectious Diseases (NIAID)
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Study Chair: Kathleen Mulligan, MD
Study Chair: Bruce R. Bistrian, MD
Study Chair: Fred R. Sattler, MD
National Institute of Allergy and Infectious Diseases (NIAID)
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP