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.

First Received: November 2, 1999 Last Updated: February 19, 2009 History of Changes

Sponsor:	Abbott
Information provided by:	Abbott
ClinicalTrials.gov Identifier:	NCT00002029

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:	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:

MedlinePlus related topics: AIDS Nutritional Support

Drug Information available for: Safflower oil

U.S. FDA Resources

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:

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.

Study ID Numbers:	041A
Study First Received:	November 2, 1999
Last Updated:	February 19, 2009
ClinicalTrials.gov Identifier:	NCT00002029 History of Changes
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:

Communicable Diseases
RNA Virus Infections
Sexually Transmitted Diseases, Viral
Disease
Slow Virus Diseases
Immune System Diseases
Acquired Immunodeficiency Syndrome
Infection

Immunologic Deficiency Syndromes
Virus Diseases
Pathologic Processes
HIV Infections
Syndrome
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections

ClinicalTrials.gov processed this record on November 30, 2009