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

NCT ID: NCT00000925

Last Updated: 2013-07-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1999-05-31

Brief 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.

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.

Conditions

HIV Infections; HIV Wasting Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

Optimune oral nutritional supplement

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kathleen Mulligan, MD

Role: STUDY_CHAIR

Bruce R. Bistrian, MD

Role: STUDY_CHAIR

Fred R. Sattler, MD

Role: STUDY_CHAIR

Locations

Univ of Southern California / LA County USC Med Ctr

Los Angeles, California, United States

UCLA CARE Ctr

Los Angeles, California, United States

San Francisco Gen Hosp

San Francisco, California, United States

Stanford Univ Med Ctr

Stanford, California, 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

Tulane Univ School of Medicine

New Orleans, Louisiana, United States

Johns Hopkins Hosp

Baltimore, Maryland, United States

St Louis Regional Hosp / St Louis Regional Med Ctr

St Louis, Missouri, United States

Chelsea Ctr

New York, New York, United States

Cornell Univ Med Ctr

New York, New York, United States

Univ of Rochester Medical Center

Rochester, New York, United States

Univ of Cincinnati

Cincinnati, Ohio, United States

Ohio State Univ Hosp Clinic

Columbus, Ohio, United States

Philadelphia Veterans Administration Med Ctr

Philadelphia, Pennsylvania, United States

Julio Arroyo

West Columbia, South Carolina, United States

Univ of Washington

Seattle, Washington, United States

Univ of Puerto Rico

San Juan, , Puerto Rico

Countries

United States; Puerto Rico

Other Identifiers

11349

Identifier Type: REGISTRY

Identifier Source: secondary_id

ACTG 392

Identifier Type: -

Identifier Source: org_study_id