San Francisco, California 94110

  • HIV Wasting Syndrome

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.


Study summary:

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.


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 is Available At:


Original ID:

ACTG 392


NCT ID:

NCT00000925


Secondary ID:

11349


Study Acronym:


Brief Title:

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


Official Title:

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


Overall Status:

Completed


Study Phase:

Phase 2


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

National Institute of Allergy and Infectious Diseases (NIAID)


Oversight Authority:

United States: Federal Government


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

56


Enrollment Type:


Overall Contact Information

Official Name:Kathleen Mulligan, MD
Study Chair

Study Dates

Start Date:May 1999
Primary Completion Date:June 2003
Primary Completion Type:Actual
Verification Date:July 2013
Last Changed Date:July 26, 2013
First Received Date:November 2, 1999

Study Outcomes

There are no available Study Outcomes

Study Interventions

Intervention Type:Drug
Name:Optimune oral nutritional supplement

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:NIH
Agency Type:Lead Sponsor
Agency Name:National Institute of Allergy and Infectious Diseases (NIAID)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: April 07, 2020

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