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

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00001077
• Other study ID #: CPCRA 038
• Secondary ID: 11588
• Status: Completed
• Phase: N/A
• First received: November 2, 1999
• Last updated: September 28, 2013
• Start date: June 1996
• Est. completion date: April 1998

Study information

• Verified date: September 2013
• Source: National Institute of Allergy and Infectious Diseases (NIAID)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 536
• Est. completion date: April 1998
• Est. primary completion date: April 1998
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 13 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• HIV Infections
• HIV Wasting Syndrome
• Weight Loss

Intervention

Dietary Supplement:
• Multivitamin and mineral supplements
Oral tablets taken daily
• Peptamen
Solution received daily
• NuBasics
Solution or dietary bar received daily

Locations

Country	Name	City	State
United States	Partners in Research - New Mexico	Albuquerque	New Mexico
United States	Partners Research	Albuquerque	New Mexico
United States	AIDS Research Consortium of Atlanta	Atlanta	Georgia
United States	Baltimore Trials	Baltimore	Maryland
United States	Southern New Jersey AIDS Cln Trials / Dept of Med	Camden	New Jersey
United States	AIDS Research Alliance - Chicago	Chicago	Illinois
United States	Rush Presbyterian - Saint Luke's Med Ctr	Chicago	Illinois
United States	Denver CPCRA / Denver Public Hlth	Denver	Colorado
United States	Henry Ford Hosp	Detroit	Michigan
United States	Wayne State Univ / WSU / DMC HIV / AIDS Program	Detroit	Michigan
United States	Louisiana Comm AIDS Rsch Prog / Tulane Univ Med	New Orleans	Louisiana
United States	Harlem AIDS Treatment Group / Harlem Hosp Ctr	New York	New York
United States	North Jersey Community Research Initiative	Newark	New Jersey
United States	Philadelphia FIGHT	Philadelphia	Pennsylvania
United States	Portland Veterans Adm Med Ctr / Rsch & Education Grp	Portland	Oregon
United States	Community Consortium / UCSF	San Francisco	California
United States	Washington Reg AIDS Prog / Dept of Infect Dis	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

United States, 

References & Publications (5)

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)

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. — View 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)

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