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

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002029
• Other study ID #: 041A
• Status: Completed
• Phase: N/A
• First received: November 2, 1999
• Last updated: February 19, 2009

Study information

• Verified date: February 2009
• Source: Abbott
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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.

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• Immunologic Deficiency Syndromes

Intervention

Drug:
• Fat Emulsion 2%

• Fat Emulsion 20%

Locations

Country	Name	City	State
United States	East Orange Veterans Administration Med Ctr	East Orange	New Jersey
United States	Intracare Inc	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Abbott

Country where clinical trial is conducted

United States, 

References & Publications (1)

Singer P, Rubinstein A, Askanazi J, Calvelli T, Lazarus T, Kirvelä 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. — View Citation