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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.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00002029
First Posted: August 31, 2001
Last Update Posted: February 20, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Abbott
  Purpose
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.

Condition Intervention
HIV Infections Drug: Fat Emulsion 2% Drug: Fat Emulsion 20%

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Long-Term Nutritional Support in Patients With the Acquired Immunodeficiency Syndrome: Comparison of Liposyn III 2 Percent With Liposyn II 20 Percent

Resource links provided by NLM:


Further study details as provided by Abbott:

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002029


Locations
United States, Florida
Intracare Inc
Miami, Florida, United States, 33126
United States, New Jersey
East Orange Veterans Administration Med Ctr
East Orange, New Jersey, United States, 07018
Sponsors and Collaborators
Abbott
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00002029     History of Changes
Other Study ID Numbers: 041A
First Submitted: November 2, 1999
First Posted: August 31, 2001
Last Update Posted: February 20, 2009
Last Verified: February 2009

Keywords provided by Abbott:
Weight Loss
Parenteral Nutrition, Total
AIDS-Related Opportunistic Infections
Liposyn
Acquired Immunodeficiency Syndrome

Additional relevant MeSH terms:
HIV Infections
Immunologic Deficiency Syndromes
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immune System Diseases
Slow Virus Diseases
Soybean oil, phospholipid emulsion
Safflower oil, soybean oil, lecithin emulsion
Safflower oil, soybean oil, phospholipid emulsion
Fat Emulsions, Intravenous
Parenteral Nutrition Solutions
Pharmaceutical Solutions