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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Abbott
• Treatments: Safflower oil, soybean oil, lecithin emulsion; Safflower oil, soybean oil, phospholipid emulsion; Soybean oil, phospholipid emulsion

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.