NCT00001077

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
536

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 1996

Geographic Reach
1 country

17 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 1996

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 1998

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 1998

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

November 2, 1999

Completed
1.8 years until next milestone

First Posted

Study publicly available on registry

August 31, 2001

Completed
Last Updated

October 1, 2013

Status Verified

September 1, 2013

Enrollment Period

1.8 years

First QC Date

November 2, 1999

Last Update Submit

September 28, 2013

Conditions

HIV InfectionsHIV Wasting Syndrome

Keywords

Weight LossAcquired Immunodeficiency SyndromeNutritional Support

Study Arms (3)

1

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

Dietary Supplement: Multivitamin and mineral supplementsDietary 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

Dietary Supplement: Multivitamin and mineral supplementsDietary Supplement: NuBasics

3

Participants will receive multivitamin and mineral supplements, taken in addition to a regular diet for 4 months

Dietary Supplement: Multivitamin and mineral supplements

Interventions

Multivitamin and mineral supplementsDIETARY_SUPPLEMENT

Oral tablets taken daily

123
PeptamenDIETARY_SUPPLEMENT

Solution received daily

1
NuBasicsDIETARY_SUPPLEMENT

Solution or dietary bar received daily

2

Eligibility Criteria

Age13 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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).
  • +19 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (17)

Community Consortium / UCSF

San Francisco, California, 94110, United States

Location

Denver CPCRA / Denver Public Hlth

Denver, Colorado, 80204, United States

Location

Washington Reg AIDS Prog / Dept of Infect Dis

Washington D.C., District of Columbia, 20422, United States

Location

AIDS Research Consortium of Atlanta

Atlanta, Georgia, 30308, United States

Location

Rush Presbyterian - Saint Luke's Med Ctr

Chicago, Illinois, 60612, United States

Location

AIDS Research Alliance - Chicago

Chicago, Illinois, 60657, United States

Location

Louisiana Comm AIDS Rsch Prog / Tulane Univ Med

New Orleans, Louisiana, 70112, United States

Location

Baltimore Trials

Baltimore, Maryland, 21201, United States

Location

Wayne State Univ / WSU / DMC HIV / AIDS Program

Detroit, Michigan, 48201, United States

Location

Henry Ford Hosp

Detroit, Michigan, 48202, United States

Location

Southern New Jersey AIDS Cln Trials / Dept of Med

Camden, New Jersey, 08103, United States

Location

North Jersey Community Research Initiative

Newark, New Jersey, 07103, United States

Location

Partners in Research - New Mexico

Albuquerque, New Mexico, 87131, United States

Location

Partners Research

Albuquerque, New Mexico, 87131, United States

Location

Harlem AIDS Treatment Group / Harlem Hosp Ctr

New York, New York, 10037, United States

Location

Portland Veterans Adm Med Ctr / Rsch & Education Grp

Portland, Oregon, 97210, United States

Location

Philadelphia FIGHT

Philadelphia, Pennsylvania, 19107, United States

Location

Related 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)

    BACKGROUND

  • 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)

    BACKGROUND

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

    PMID: 9625392BACKGROUND

  • 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)

    BACKGROUND

  • 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.

    PMID: 10770345BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Blood collection

MeSH Terms

Conditions

HIV InfectionsHIV Wasting SyndromeWeight LossAcquired Immunodeficiency Syndrome

Interventions

GeritolPeptamen

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesWasting SyndromeMetabolic DiseasesNutritional and Metabolic DiseasesNutrition DisordersBody Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsSlow Virus Diseases

Study Officials

  • Gilbert CL

    STUDY CHAIR

  • Wheeler D

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 2, 1999

First Posted

August 31, 2001

Study Start

June 1, 1996

Primary Completion

April 1, 1998

Study Completion

April 1, 1998

Last Updated

October 1, 2013

Record last verified: 2013-09

Locations

US(17)