Clinical trial NCT00001077: A Comparison of Two Caloric Supplements in the Prevention of Weight Loss in Patients With AIDS Who Take Daily Multivitamin and Mineral Supplements
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV Infections
HIV Wasting Syndrome
Keywords: Weight Loss
Acquired Immunodeficiency Syndrome
Nutritional Support
Lead sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Sponsor class: NIH
First posted: 2001-08-31
Enrollment: 536
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: HIV-infected participants who take a daily multivitamin and mineral supplement

Brief summary: 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.

Detailed description: 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 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Community Consortium / UCSF
state: California
city: Denver
country: United States
facility: Denver CPCRA / Denver Public Hlth
state: Colorado
city: Washington
country: United States
facility: Washington Reg AIDS Prog / Dept of Infect Dis
state: District of Columbia
city: Atlanta
country: United States
facility: AIDS Research Consortium of Atlanta
state: Georgia
city: Chicago
country: United States
facility: Rush Presbyterian - Saint Luke's Med Ctr
state: Illinois
city: Chicago
country: United States
facility: AIDS Research Alliance - Chicago
state: Illinois
city: New Orleans
country: United States
facility: Louisiana Comm AIDS Rsch Prog / Tulane Univ Med
state: Louisiana
city: Baltimore
country: United States
facility: Baltimore Trials
state: Maryland
city: Detroit
country: United States
facility: Wayne State Univ / WSU / DMC HIV / AIDS Program
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Hosp
state: Michigan
city: Camden
country: United States
facility: Southern New Jersey AIDS Cln Trials / Dept of Med
state: New Jersey
city: Newark
country: United States
facility: North Jersey Community Research Initiative
state: New Jersey
city: Albuquerque
country: United States
facility: Partners in Research - New Mexico
state: New Mexico
city: Albuquerque
country: United States
facility: Partners Research
state: New Mexico
city: New York
country: United States
facility: Harlem AIDS Treatment Group / Harlem Hosp Ctr
state: New York
city: Portland
country: United States
facility: Portland Veterans Adm Med Ctr / Rsch & Education Grp
state: Oregon
city: Philadelphia
country: United States
facility: Philadelphia FIGHT
state: Pennsylvania
Study officials:
name: Gilbert CL
role: STUDY_CHAIR
name: Wheeler D
role: STUDY_CHAIR
References:
citation: Gibert CL, Muurahainen N, Collins G, Williams B, Raghavan S, Bartsch G, Wheeler D. Body composition in HIV-infected men and women in 1996-1997 (CPCRA 038). Int Conf AIDS. 1998;12:554 (abstract no 32169)
citation: Williams SB, Collins G, Muurahainen N, Bartsch G, Gibert C, Raghavan SS, Wheeler D. Protein intake is associated with body cell mass in weight-stable HIV+ men with CD4 < 200 cells/mm3: CPCRA 038. Int Conf AIDS. 1998;12:841-2 (abstract no 42339)
citation: Muurahainen N, Mulligan K. Clinical trials update in human immunodeficiency virus wasting. Semin Oncol. 1998 Apr;25(2 Suppl 6):104-11.
citation: Muurahainen N, Collins G, Wheeler D, Mateo N, Madans M, Bartsch G, Gilbert C. Body cell mass (BCM) in HIV-infected (HIV+) males in the community programs for clinical research on AIDS (CPCRA) in 1996-1997. Int Conf AIDS. 1998;12:840 (abstract no 42333)
citation: Gibert CL, Wheeler DA, Collins G, Madans M, Muurahainen N, Raghavan SS, Bartsch G. Randomized, controlled trial of caloric supplements in HIV infection. Terry Beirn Community Programs for Clinical Research on AIDS. J Acquir Immune Defic Syndr. 1999 Nov 1;22(3):253-9. doi: 10.1097/00126334-199911010-00006.