NCT Number: NCT00002029
Long-Term Nutritional Support in Patients With the Acquired Immunodeficiency Syndrome: Comparison of Liposyn III 2 Percent With Liposyn II 20 Percent
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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Notify MeKey information
Conditions
Age range
18 year–60 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Intracare Inc, Miami, Florida, United States
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
Fat Emulsion 20%
DrugSponsors and collaborators
Lead sponsor
Abbott
Industry
Registry information
Important dates
- First posted
- Aug 31, 2001
- Registry last updated
- Feb 20, 2009
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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