- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00002275
A Comparison of Two Types of Injected Nutritional Supplements in Patients With AIDS and Pneumocystis Carinii Pneumonia (PCP)
Lipid-Based Parenteral Nutritional Support in Patients With the Acquired Immunodeficiency Syndrome and Pneumocystis Carinii Pneumonia. A Comparison of Two Lipid Formulations
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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
New Jersey
-
East Orange, New Jersey, United States, 07018
- East Orange Veterans Administration Med Ctr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria
Concurrent Medication:
Allowed:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- RNA Virus Infections
- Virus Diseases
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Blood-Borne Infections
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immunologic Deficiency Syndromes
- Immune System Diseases
- Lung Diseases
- Bacterial Infections and Mycoses
- Mycoses
- Slow Virus Diseases
- HIV Infections
- Lung Diseases, Fungal
- Pneumocystis Infections
- Pneumonia
- Acquired Immunodeficiency Syndrome
- Pneumonia, Pneumocystis
- Pharmaceutical Solutions
- Parenteral Nutrition Solutions
- Fat Emulsions, Intravenous
- Soybean oil, phospholipid emulsion
Other Study ID Numbers
- 041B
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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