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Long-Term Nutritional Support in Patients With the Acquired Immunodeficiency Syndrome: Comparison of Liposyn III 2 Percent With Liposyn II 20 Percent

Primary Purpose

HIV Infections

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Fat Emulsion 2%
Fat Emulsion 20%
Sponsored by
Abbott
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring Weight Loss, Parenteral Nutrition, Total, AIDS-Related Opportunistic Infections, Liposyn, Acquired Immunodeficiency Syndrome

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria Concurrent Medication: Allowed: Zidovudine (AZT). All drugs used for the standard treatment of opportunistic infections. Other drugs used for the treatment of other AIDS conditions if they have been started more than 3 months prior to study entry. Patients must have: Diagnosis of AIDS. Weight loss of > 10 percent premorbid body weight. Presenting diagnosis of either opportunistic infection or Kaposi's sarcoma. Require home total parenteral nutrition (TPN) for a period of approximately 3 months. Life expectancy = or > 90 days. Prior Medication: Allowed: Zidovudine (AZT). Exclusion Criteria Co-existing Condition: Patients with the following conditions or symptoms are excluded: Life expectancy < 90 days. Biliary stasis. History of drug abuse. Patients with the following are excluded: Life expectancy < 90 days. Biliary stasis. History of drug abuse. Prior Medication: Excluded within 3 months of study entry: Immunomodulators. Experimental antiviral DT. History of drug abuse.

Sites / Locations

  • Intracare Inc
  • East Orange Veterans Administration Med Ctr

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
February 19, 2009
Sponsor
Abbott
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1. Study Identification

Unique Protocol Identification Number
NCT00002029
Brief Title
Long-Term Nutritional Support in Patients With the Acquired Immunodeficiency Syndrome: Comparison of Liposyn III 2 Percent With Liposyn II 20 Percent
Official Title
Long-Term Nutritional Support in Patients With the Acquired Immunodeficiency Syndrome: Comparison of Liposyn III 2 Percent With Liposyn II 20 Percent
Study Type
Interventional

2. Study Status

Record Verification Date
February 2009
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Abbott

4. Oversight

5. Study Description

Brief Summary
To compare two lipid emulsions in the long-term parenteral alimentation of patients with AIDS in relation to: Clinical effectiveness. Effect on immunologic function. Effect on HIV load as measured by p24 antigen levels. Effect on relative HIV infectivity.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Weight Loss, Parenteral Nutrition, Total, AIDS-Related Opportunistic Infections, Liposyn, Acquired Immunodeficiency Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Fat Emulsion 2%
Intervention Type
Drug
Intervention Name(s)
Fat Emulsion 20%

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria Concurrent Medication: Allowed: Zidovudine (AZT). All drugs used for the standard treatment of opportunistic infections. Other drugs used for the treatment of other AIDS conditions if they have been started more than 3 months prior to study entry. Patients must have: Diagnosis of AIDS. Weight loss of > 10 percent premorbid body weight. Presenting diagnosis of either opportunistic infection or Kaposi's sarcoma. Require home total parenteral nutrition (TPN) for a period of approximately 3 months. Life expectancy = or > 90 days. Prior Medication: Allowed: Zidovudine (AZT). Exclusion Criteria Co-existing Condition: Patients with the following conditions or symptoms are excluded: Life expectancy < 90 days. Biliary stasis. History of drug abuse. Patients with the following are excluded: Life expectancy < 90 days. Biliary stasis. History of drug abuse. Prior Medication: Excluded within 3 months of study entry: Immunomodulators. Experimental antiviral DT. History of drug abuse.
Facility Information:
Facility Name
Intracare Inc
City
Miami
State/Province
Florida
ZIP/Postal Code
33126
Country
United States
Facility Name
East Orange Veterans Administration Med Ctr
City
East Orange
State/Province
New Jersey
ZIP/Postal Code
07018
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
1556814
Citation
Singer P, Rubinstein A, Askanazi J, Calvelli T, Lazarus T, Kirvela O, Katz DP. Clinical and immunologic effects of lipid-based parenteral nutrition in AIDS. JPEN J Parenter Enteral Nutr. 1992 Mar-Apr;16(2):165-7. doi: 10.1177/0148607192016002165.
Results Reference
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Long-Term Nutritional Support in Patients With the Acquired Immunodeficiency Syndrome: Comparison of Liposyn III 2 Percent With Liposyn II 20 Percent

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