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

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.

HIV-infected participants who take a daily multivitamin and mineral supplement

• HIV Infections
• HIV Wasting Syndrome

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

• 1
  Participants will receive peptamen drinks and multivitamin and mineral supplements, taken in addition to a regular diet for 4 months
  Interventions:

  • Dietary Supplement: Multivitamin and mineral supplements
  • Dietary Supplement: Peptamen
• 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
  Interventions:

  • Dietary Supplement: Multivitamin and mineral supplements
  • Dietary Supplement: NuBasics
• 3
  Participants will receive multivitamin and mineral supplements, taken in addition to a regular diet for 4 months
  Intervention: Dietary Supplement: Multivitamin and mineral supplements

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

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.