A Comparison of Two Types of Injected Nutritional Supplements in Patients With AIDS and Pneumocystis Carinii Pneumonia (PCP)

This study has been completed.

Sponsor:

Information provided by:

Abbott

ClinicalTrials.gov Identifier:

NCT00002275

First received: November 2, 1999

Last updated: February 19, 2009

Last verified: February 2009

History of Changes

Tracking Information
First Received Date ^ICMJE	November 2, 1999
Last Updated Date	February 19, 2009
Start Date ^ICMJE	Not Provided
Primary Completion Date	Not Provided
Current Primary Outcome Measures ^ICMJE	Not Provided
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT00002275 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	A Comparison of Two Types of Injected Nutritional Supplements in Patients With AIDS and Pneumocystis Carinii Pneumonia (PCP)
Official Title ^ICMJE	Lipid-Based Parenteral Nutritional Support in Patients With the Acquired Immunodeficiency Syndrome and Pneumocystis Carinii Pneumonia. A Comparison of Two Lipid Formulations
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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Primary Purpose: Treatment
Condition ^ICMJE	HIV Infections
Intervention ^ICMJE	Drug: Fat Emulsion 2% Drug: Fat Emulsion 20%
Study Arm (s)	Not Provided
Publications *	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.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	Not Provided
Completion Date	Not Provided
Primary Completion Date	Not Provided
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years to 60 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00002275
Other Study ID Numbers ^ICMJE	041B
Has Data Monitoring Committee	Not Provided
Responsible Party	Not Provided
Study Sponsor ^ICMJE	Abbott
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Abbott
Verification Date	February 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top