|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsored by: |
National Institute of Allergy and Infectious Diseases (NIAID) |
|---|---|
| Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
| ClinicalTrials.gov Identifier: | NCT00001077 |
Purpose
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.
| Condition | Intervention |
|---|---|
|
HIV Infections HIV Wasting Syndrome |
Dietary Supplement: Multivitamin and mineral supplements Dietary Supplement: Peptamen Dietary Supplement: NuBasics |
| Study Type: | Observational |
| Study Design: | Cohort, Prospective |
| Official Title: | An 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 |
Blood collection
| Enrollment: | 536 |
| Study Start Date: | June 1996 |
| Primary Completion Date: | June 1998 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
1
Participants will receive peptamen drinks and multivitamin and mineral supplements, taken in addition to a regular diet for 4 months
|
Dietary Supplement: Multivitamin and mineral supplements
Oral tablets taken daily
Dietary Supplement: Peptamen
Solution received daily
|
|
2
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
|
Dietary Supplement: Multivitamin and mineral supplements
Oral tablets taken daily
Dietary Supplement: NuBasics
Solution or dietary bar received daily
|
|
3
Participants will receive multivitamin and mineral supplements, taken in addition to a regular diet for 4 months
|
Dietary Supplement: Multivitamin and mineral supplements
Oral tablets taken daily
|
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.
Eligibility| Ages Eligible for Study: | 13 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
HIV-infected participants who take a daily multivitamin and mineral supplement
Inclusion Criteria
Patients must have:
Exclusion Criteria
Co-existing Condition:
Patients with any of the following symptoms or conditions are excluded:
Concurrent Medication:
Excluded:
NOTE:
Patients with the following prior condition are excluded:
Prior Medication:
Excluded within the past 2 weeks:
Excluded within the past 30 days:
NOTE:
Contacts and Locations| United States, California | |
| Community Consortium / UCSF | |
| San Francisco, California, United States, 94110 | |
| United States, Colorado | |
| Denver CPCRA / Denver Public Hlth | |
| Denver, Colorado, United States, 802044507 | |
| United States, District of Columbia | |
| Washington Reg AIDS Prog / Dept of Infect Dis | |
| Washington, District of Columbia, United States, 20422 | |
| United States, Georgia | |
| AIDS Research Consortium of Atlanta | |
| Atlanta, Georgia, United States, 30308 | |
| United States, Illinois | |
| Rush Presbyterian - Saint Luke's Med Ctr | |
| Chicago, Illinois, United States, 60612 | |
| AIDS Research Alliance - Chicago | |
| Chicago, Illinois, United States, 60657 | |
| United States, Louisiana | |
| Louisiana Comm AIDS Rsch Prog / Tulane Univ Med | |
| New Orleans, Louisiana, United States, 70112 | |
| United States, Maryland | |
| Baltimore Trials | |
| Baltimore, Maryland, United States, 21201 | |
| United States, Michigan | |
| Henry Ford Hosp | |
| Detroit, Michigan, United States, 48202 | |
| Wayne State Univ / WSU / DMC HIV / AIDS Program | |
| Detroit, Michigan, United States, 48201 | |
| United States, New Jersey | |
| North Jersey Community Research Initiative | |
| Newark, New Jersey, United States, 071032842 | |
| Southern New Jersey AIDS Cln Trials / Dept of Med | |
| Camden, New Jersey, United States, 08103 | |
| United States, New Mexico | |
| Partners Research | |
| Albuquerque, New Mexico, United States, 871315271 | |
| Partners in Research - New Mexico | |
| Albuquerque, New Mexico, United States, 87131 | |
| United States, New York | |
| Harlem AIDS Treatment Group / Harlem Hosp Ctr | |
| New York, New York, United States, 10037 | |
| United States, Oregon | |
| Portland Veterans Adm Med Ctr / Rsch & Education Grp | |
| Portland, Oregon, United States, 972109951 | |
| United States, Pennsylvania | |
| Philadelphia FIGHT | |
| Philadelphia, Pennsylvania, United States, 19107 | |
| Study Chair: | Gilbert CL | |
| Study Chair: | Wheeler D |
More Information
| Responsible Party: | DAIDS ( Rona Siskind ) |
| Study ID Numbers: | CPCRA 038 |
| Study First Received: | November 2, 1999 |
| Last Updated: | September 25, 2008 |
| ClinicalTrials.gov Identifier: | NCT00001077 History of Changes |
| Health Authority: | United States: Federal Government |
|
Weight Loss Acquired Immunodeficiency Syndrome Nutritional Support |
|
Sexually Transmitted Diseases, Viral Metabolic Diseases HIV Wasting Syndrome Acquired Immunodeficiency Syndrome Immunologic Deficiency Syndromes Body Weight Virus Diseases Signs and Symptoms |
HIV Infections Weight Loss Sexually Transmitted Diseases Body Weight Changes Nutrition Disorders Wasting Syndrome Metabolic Disorder Retroviridae Infections |
|
RNA Virus Infections Sexually Transmitted Diseases, Viral Metabolic Diseases Disease Slow Virus Diseases Immune System Diseases HIV Wasting Syndrome Acquired Immunodeficiency Syndrome Infection Immunologic Deficiency Syndromes Body Weight Virus Diseases |
Signs and Symptoms Pathologic Processes HIV Infections Syndrome Weight Loss Sexually Transmitted Diseases Body Weight Changes Lentivirus Infections Nutrition Disorders Wasting Syndrome Retroviridae Infections |