NCT00002275CompletedNot Applicable
Lipid-Based Parenteral Nutritional Support in Patients With the Acquired Immunodeficiency Syndrome and Pneumocystis Carinii Pneumonia. A Comparison of Two Lipid Formulations
Abbott1 site in 1 countryStarted: August 31, 2001Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Locations
- 1
Study Overview
Brief Summary
The objectives of this study are:
To establish whether there is a difference in clinical effectiveness of Liposyn II 20 percent as compared with Liposyn III 2 percent in AIDS patients with Pneumocystis carinii pneumonia (PCP). To compare the effects of the two lipid emulsions on immunologic function in AIDS patients. To compare the effect of the two lipid emulsions on HIV load in AIDS patients as measured by reverse transcriptase (RT) in culture. To determine whether a decrease in HIV infectivity is greater in patients given a parenteral feeding regimen containing Liposyn II 20 percent or Liposyn III 2 percent.
Study Design
- Study Type
- Interventional
- Primary Purpose
- Treatment
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Concurrent Medication:
- •All drugs used for the standard treatment of Pneumocystis carinii pneumonia (PCP).
- •Other drugs for 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 > 10 percent of premorbid body weight.
- •First or second episode of acute Pneumocystis carinii pneumonia (PCP).
Exclusion Criteria
- •Co-existing Condition:
- •Patients with the following conditions or symptoms are excluded:
- •Do Not Resuscitate (DNR) status.
- •Biliary stasis.
- •Patients with the following are excluded:
- •Do Not Resuscitate (DNR) status.
- •Biliary stasis.
- •Prior Medication:
- •Excluded within 3 months of study entry:
- •Immunomodulators.
- •Antiviral new DT
Investigators
Study Sites (1)
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