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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Brief Summary

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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.

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Detailed Description

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Conditions

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HIV Infections

Study Design

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Primary Study Purpose

TREATMENT

Interventions

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Fat Emulsion 2%

Intervention Type DRUG

Fat Emulsion 20%

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No