Back to resultsA Comparison of Two Types of Injected Nutritional Supplements in Patients With AIDS and Pneumocystis Carinii Pneumonia (PCP)
Primary Purpose
HIV Infections
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Fat Emulsion 2%
Fat Emulsion 20%
Sponsored by
About this trial
This is an interventional treatment trial for HIV Infections focused on measuring Weight Loss, Pneumonia, Pneumocystis carinii, Parenteral Nutrition, Liposyn, Acquired Immunodeficiency Syndrome
Eligibility Criteria
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
Sites / Locations
- East Orange Veterans Administration Med Ctr
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00002275
Brief Title
A Comparison of Two Types of Injected Nutritional Supplements in Patients With AIDS and Pneumocystis Carinii Pneumonia (PCP)
Official Title
Lipid-Based Parenteral Nutritional Support in Patients With the Acquired Immunodeficiency Syndrome and Pneumocystis Carinii Pneumonia. A Comparison of Two Lipid Formulations
Study Type
Interventional
2. Study Status
Record Verification Date
February 2009
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Abbott
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Weight Loss, Pneumonia, Pneumocystis carinii, Parenteral Nutrition, Liposyn, Acquired Immunodeficiency Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Fat Emulsion 2%
Intervention Type
Drug
Intervention Name(s)
Fat Emulsion 20%
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
East Orange Veterans Administration Med Ctr
City
East Orange
State/Province
New Jersey
ZIP/Postal Code
07018
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
7993207
Citation
Martin DF, Parks DJ, Mellow SD, Ferris FL, Walton RC, Remaley NA, Chew EY, Ashton P, Davis MD, Nussenblatt RB. Treatment of cytomegalovirus retinitis with an intraocular sustained-release ganciclovir implant. A randomized controlled clinical trial. Arch Ophthalmol. 1994 Dec;112(12):1531-9. doi: 10.1001/archopht.1994.01090240037023.
Results Reference
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A Comparison of Two Types of Injected Nutritional Supplements in Patients With AIDS and Pneumocystis Carinii Pneumonia (PCP)
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