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

Abbott

Status: Completed

Conditions: HIV Infections

Treatments: Drug: Fat Emulsion 20%; Drug: Fat Emulsion 2%

Study type: Interventional

Funder types: Industry

Identifiers

NCT00002029

041A

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.