A Study to Evaluate High Protein Supplementation in HIV-Positive Patients With Stable Weight Loss
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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.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infections HIV Wasting Syndrome |
Drug: Optimune oral nutritional supplement |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | Evaluation of High Protein Supplementation in HIV-1-Positive Subjects With Stable Weight Loss |
| Estimated Enrollment: | 56 |
| Study Start Date: | May 1999 |
| Primary Completion Date: | June 2003 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations| United States, California | |
| UCLA CARE Ctr | |
| Los Angeles, California, United States, 90095 | |
| Univ of Southern California / LA County USC Med Ctr | |
| Los Angeles, California, United States, 900331079 | |
| San Francisco Gen Hosp | |
| San Francisco, California, United States, 941102859 | |
| Stanford Univ Med Ctr | |
| Stanford, California, United States, 943055107 | |
| United States, Colorado | |
| Univ of Colorado Health Sciences Ctr | |
| Denver, Colorado, United States, 80262 | |
| United States, Hawaii | |
| Queens Med Ctr | |
| Honolulu, Hawaii, United States, 96816 | |
| Univ of Hawaii | |
| Honolulu, Hawaii, United States, 96816 | |
| United States, Louisiana | |
| Tulane Univ School of Medicine | |
| New Orleans, Louisiana, United States, 70112 | |
| United States, Maryland | |
| Johns Hopkins Hosp | |
| Baltimore, Maryland, United States, 21287 | |
| United States, Missouri | |
| St Louis Regional Hosp / St Louis Regional Med Ctr | |
| St Louis, Missouri, United States, 63112 | |
| United States, New York | |
| Cornell Univ Med Ctr | |
| New York, New York, United States, 10021 | |
| Chelsea Ctr | |
| New York, New York, United States, 10021 | |
| Univ of Rochester Medical Center | |
| Rochester, New York, United States, 14642 | |
| United States, Ohio | |
| Univ of Cincinnati | |
| Cincinnati, Ohio, United States, 452670405 | |
| Ohio State Univ Hosp Clinic | |
| Columbus, Ohio, United States, 432101228 | |
| United States, Pennsylvania | |
| Philadelphia Veterans Administration Med Ctr | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| United States, South Carolina | |
| Julio Arroyo | |
| West Columbia, South Carolina, United States, 29169 | |
| United States, Washington | |
| Univ of Washington | |
| Seattle, Washington, United States, 98104 | |
| Puerto Rico | |
| Univ of Puerto Rico | |
| San Juan, Puerto Rico, 009365067 | |
| Study Chair: | Kathleen Mulligan, MD | |
| Study Chair: | Bruce R. Bistrian, MD | |
| Study Chair: | Fred R. Sattler, MD |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00000925 History of Changes |
| Other Study ID Numbers: | ACTG 392 |
| Study First Received: | November 2, 1999 |
| Last Updated: | February 23, 2011 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
|
Dietary Proteins HIV Wasting Syndrome |
Additional relevant MeSH terms:
|
HIV Infections Acquired Immunodeficiency Syndrome Wasting Syndrome Weight Loss HIV Wasting Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral |
Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Metabolic Diseases Nutrition Disorders Body Weight Changes Body Weight Signs and Symptoms |
ClinicalTrials.gov processed this record on March 07, 2013
