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

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00000925
• Other study ID #: ACTG 392
• Secondary ID: 11349
• Status: Completed
• Phase: Phase 2
• First received: November 2, 1999
• Last updated: July 26, 2013
• Start date: May 1999

Study information

• Verified date: July 2013
• Source: National Institute of Allergy and Infectious Diseases (NIAID)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. primary completion date: June 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infections
• HIV Wasting Syndrome

Intervention

Drug:
• Optimune oral nutritional supplement

Locations

Country	Name	City	State
Puerto Rico	Univ of Puerto Rico	San Juan
United States	Johns Hopkins Hosp	Baltimore	Maryland
United States	Univ of Cincinnati	Cincinnati	Ohio
United States	Ohio State Univ Hosp Clinic	Columbus	Ohio
United States	Univ of Colorado Health Sciences Ctr	Denver	Colorado
United States	Queens Med Ctr	Honolulu	Hawaii
United States	Univ of Hawaii	Honolulu	Hawaii
United States	UCLA CARE Ctr	Los Angeles	California
United States	Univ of Southern California / LA County USC Med Ctr	Los Angeles	California
United States	Tulane Univ School of Medicine	New Orleans	Louisiana
United States	Chelsea Ctr	New York	New York
United States	Cornell Univ Med Ctr	New York	New York
United States	Philadelphia Veterans Administration Med Ctr	Philadelphia	Pennsylvania
United States	Univ of Rochester Medical Center	Rochester	New York
United States	San Francisco Gen Hosp	San Francisco	California
United States	Univ of Washington	Seattle	Washington
United States	St Louis Regional Hosp / St Louis Regional Med Ctr	St Louis	Missouri
United States	Stanford Univ Med Ctr	Stanford	California
United States	Julio Arroyo	West Columbia	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)

Countries where clinical trial is conducted

United States,  Puerto Rico, 

External Links

•   Haga clic aquí para ver información sobre este ensayo clínico en español.