Completed

A Comparison of Two Caloric Supplements in the Prevention of Weight Loss in Patients With AIDS Who Take Daily Multivitamin and Mineral Supplements

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What is being collected

Dietary Supplement Data

+ dietarySupplement Data
Collected from today forward - Prospective
Dietary Supplement
DNA Samples
Who is being recruted

HIV Infections

+ HIV Wasting Syndrome
Over 13 Years
How is the trial designed

Cohort

Tracking disease incidence in order to identify risk factors and understand disease progression over time.
Observational
Study Start: June 1996

Summary

Principal SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Last updated: October 1, 2013
Sourced from a government-validated database.Claim as a partner
Study start date: June 1, 1996Actual date on which the first participant was enrolled.

To compare a caloric supplement containing peptides and medium-chain triglycerides, a caloric supplement containing whole protein and long-chain triglycerides, and no caloric supplement for the prevention of weight loss in individuals with AIDS who take a daily multivitamin and mineral supplement. Patients will be randomized to one of 3 study arms: Arm 1 - Peptamen drinks + multivitamin and mineral supplement, taken in addition to regular diet for 4 months Arm 2 - NuBasics drinks or equivalent amounts of NuBasics soups or bars + multivitamin and mineral supplement, taken in addition to regular diet for 4 months Arm 3 - Multivitamin and mineral supplement, taken in addition to regular diet for 4 months. At months 0, 2, and 4, patients will be assessed for weight, body cell mass, patient-reported physical activity level, and dietary intake (by 24-hour dietary recall). At months 2 and 4, they will also be assessed for compliance with study regimen. Patients who complete their 4 month follow up visit will be provided with a 30 day supply of the caloric supplement of their choice (Peptamen or NuBasics) and a 30 day supply of the study multivitamin supplement.

Official TitleAn Open-Label, Randomized, Three-Arm, Comparative Trial of a Caloric Supplement With Peptides and Medium-Chain Triglycerides Versus a Caloric Supplement With Whole Protein and Long-Chain Triglycerides Versus No Caloric Supplement for the Prevention of Weight Loss in Individuals With AIDS Who Take a Daily Multivitamin and Mineral Supplement 
Principal SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Last updated: October 1, 2013
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
536 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Cohort
These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.

What happens to patients' samples
Samples from participants are kept, and they can be used to extract DNA in the future. These might include things like blood or frozen tissue. This allows researchers to study genetics and how DNA may relate to the disease.

Other Options for Sample Use
Samples Without DNA
: Samples are kept but not usable for DNA analysis.

None Retained
: No samples are kept after the study.

How participants are selected
Participants are selected without using randomization. They may be chosen based on convenience, access, or willingness to participate. This approach is common when random selection isn’t practical.
Another way to select participants is through a probability sample, where participants are chosen randomly, so everyone has an equal chance to be included.

How information is collected
Researchers start collecting data from the present day forward, following participants over time to observe outcomes. This approach helps identify how exposures or behaviors may lead to health events in the future.Other Ways to Collect Data
Retrospective
: These studies use existing medical records or past data.

Cross-sectional
: These studies collect data at one single point in time.

Others
: Some studies use a mix of approaches or less common designs depending on the research goal.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 13 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
HIV Infections
HIV Wasting Syndrome
Criteria

Inclusion Criteria Patients must have: * HIV infection. * Stable weight. * CD4+ cell count \<200 cells/mm3. * Life expectancy of at least 6 months. * Parent or legal guardian to sign written, informed consent for patients \< 18 years old. Exclusion Criteria Co-existing Condition: Patients with any of the following symptoms or conditions are excluded: * Active opportunistic infection, requiring acute treatment. * Malignancy (other than stable cutaneous Kaposi's sarcoma that does not require systemic chemotherapy). * Diabetes mellitus or other conditions requiring special dietary restrictions. * Body mass index (BMI) \>= 29.0 kg/m2. * Disorders or conditions that, in the treating clinician's opinion, may prevent adequate compliance with protocol requirements. Concurrent Medication: Excluded: * Growth hormone. * Megestrol acetate (Megace). * Cyproheptadine (Periactin). * Dronabinol (Marinol). * Thalidomide. * Anabolic steroids (e.g., nandrolone decanoate)(Deca-durabolin). * Pharmacologic-dose corticosteroids (e.g., \> 15 mg/day prednisone equivalent) NOTE: * Men requiring testosterone replacement therapy for documented hypogonadism may be enrolled. * Caloric nutritional supplements deemed by the clinician to promote weight gain or maintenance. Patients with the following prior condition are excluded: * History of phenylketonuria. Prior Medication: Excluded within the past 2 weeks: * Use of caloric nutritional supplements for more than 5 days deemed by the clinician to promote weight gain or maintenance. Excluded within the past 30 days: * Growth hormone. * Megestrol acetate (Megace). * Cyproheptadine (Periactin). * Dronabinol (Marinol). * Thalidomide. * Anabolic steroids (e.g., nandrolone decanoate)(Deca-durabolin) * Pharmacologic-dose corticosteroids (e.g., \> 15 mg/day prednisone equivalent). NOTE: * Men requiring testosterone replacement therapy for documented hypogonadism may be enrolled.


Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
3 intervention groups 

are designated in this study

This study does not include a placebo group 

Treatment Groups
Group I
Participants will receive peptamen drinks and multivitamin and mineral supplements, taken in addition to a regular diet for 4 months
Group II
Participants will receive NuBasics drinks or equivalent amounts of NuBasics soups or bars and daily multivitamin and mineral supplements, taken in addition to a regular diet for 4 months
Group III
Participants will receive multivitamin and mineral supplements, taken in addition to a regular diet for 4 months

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 17 locations
Suspended
Community Consortium / UCSFSan Francisco, United StatesSee the location
Suspended
Denver CPCRA / Denver Public HlthDenver, United States
Suspended
Washington Reg AIDS Prog / Dept of Infect DisWashington, United States
Suspended
AIDS Research Consortium of AtlantaAtlanta, United States

Completed17 Study Centers