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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


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)

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