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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:
Information provided by:
Abbott
ClinicalTrials.gov Identifier:
NCT00002029
First received: November 2, 1999
Last updated: February 19, 2009
Last verified: February 2009
History of Changes
  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:

U.S. FDA Resources

Further study details as provided by Abbott:

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: November 2, 1999
Last Updated: February 19, 2009
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immunologic Deficiency Syndromes
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
 Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on May 16, 2013