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

Original Study ID : CPCRA 038

NCT ID : NCT00001077

Brief Title : 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

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.

Source : National Institute of Allergy and Infectious Diseases (NIAID)

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.

Overall Status : Active, not recruiting

Start Date : June 1996

Official Title : N/A

Phase : Observational

Study Design : Cohort, Prospective

Enrollment : 536

Verification Date : September 2008

First Received Date : November 2, 1999

Trial 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.

Gender : Both

Minimum Age : 13 Years

Maximum Age : N/A

Healthy Volunteers : No

Facilities

Facility Name : Community Consortium / UCSF

City : San Francisco

State : California

Zip Code : 94110

Country : United States

Facility Name : Denver CPCRA / Denver Public Hlth

City : Denver

State : Colorado

Zip Code : 802044507

Country : United States

Facility Name : Washington Reg AIDS Prog / Dept of Infect Dis

City : Washington

State : District of Columbia

Zip Code : 20422

Country : United States

Facility Name : AIDS Research Consortium of Atlanta

City : Atlanta

State : Georgia

Zip Code : 30308

Country : United States

Facility Name : Rush Presbyterian - Saint Luke's Med Ctr

City : Chicago

State : Illinois

Zip Code : 60612

Country : United States

Facility Name : AIDS Research Alliance - Chicago

City : Chicago

State : Illinois

Zip Code : 60657

Country : United States

Facility Name : Louisiana Comm AIDS Rsch Prog / Tulane Univ Med

City : New Orleans

State : Louisiana

Zip Code : 70112

Country : United States

Facility Name : Baltimore Trials

City : Baltimore

State : Maryland

Zip Code : 21201

Country : United States

Facility Name : Henry Ford Hosp

City : Detroit

State : Michigan

Zip Code : 48202

Country : United States

Facility Name : Wayne State Univ / WSU / DMC HIV / AIDS Program

City : Detroit

State : Michigan

Zip Code : 48201

Country : United States

Facility Name : North Jersey Community Research Initiative

City : Newark

State : New Jersey

Zip Code : 071032842

Country : United States

Facility Name : Southern New Jersey AIDS Cln Trials / Dept of Med

City : Camden

State : New Jersey

Zip Code : 08103

Country : United States

Facility Name : Partners Research

City : Albuquerque

State : New Mexico

Zip Code : 871315271

Country : United States

Facility Name : Partners in Research - New Mexico

City : Albuquerque

State : New Mexico

Zip Code : 87131

Country : United States

Facility Name : Harlem AIDS Treatment Group / Harlem Hosp Ctr

City : New York

State : New York

Zip Code : 10037

Country : United States

Facility Name : Portland Veterans Adm Med Ctr / Rsch & Education Grp

City : Portland

State : Oregon

Zip Code : 972109951

Country : United States

Facility Name : Philadelphia FIGHT

City : Philadelphia

State : Pennsylvania

Zip Code : 19107

Country : United States

Refferances

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)

PMID : 9625392

Citation : Muurahainen N, Mulligan K. Clinical trials update in human immunodeficiency virus wasting. Semin Oncol. 1998 Apr;25(2 Suppl 6):104-11. Review.

PMID : 9625392

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)

PMID : 10770345

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.

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