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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
This study has been completed.
Study NCT00002029   Information provided by Abbott
First Received: November 2, 1999   Last Updated: February 19, 2009   History of Changes

November 2, 1999
February 19, 2009
 
 
 
 
Complete list of historical versions of study NCT00002029 on ClinicalTrials.gov Archive Site
 
 
 
Long-Term Nutritional Support in Patients With the Acquired Immunodeficiency Syndrome: Comparison of Liposyn III 2 Percent With Liposyn II 20 Percent
Long-Term Nutritional Support in Patients With the Acquired Immunodeficiency Syndrome: Comparison of Liposyn III 2 Percent With Liposyn II 20 Percent

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.

 
 
Interventional
Treatment
HIV Infections
  • Drug: Fat Emulsion 2%
  • Drug: Fat Emulsion 20%
 
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.

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
 
 
 

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.
Both
18 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00002029
 
041A
Abbott
 
 
Abbott
February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP