Evaluation of High Protein Supplementation in HIV-1-Positive Subjects With Stable Weight Loss
Data Collection
Blood-Borne Infections+16
+ Urogenital Diseases
+ Genital Diseases
Treatment Study
Summary
Study start date: May 1, 1999
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.56 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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 Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 19 locations
Univ of Southern California / LA County USC Med Ctr
Los Angeles, United StatesOpen Univ of Southern California / LA County USC Med Ctr in Google MapsUCLA CARE Ctr
Los Angeles, United StatesSan Francisco Gen Hosp
San Francisco, United StatesStanford Univ Med Ctr
Stanford, United States