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

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Abbott

Status

Completed

Conditions

HIV Infections

Treatments

Drug: Fat Emulsion 2%
Drug: Fat Emulsion 20%

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.

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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