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

This study has been completed.

First Received on November 2, 1999. Last Updated on February 19, 2009 History of Changes

Sponsor:	Abbott
Information provided by:	Abbott
ClinicalTrials.gov Identifier:	NCT00002275

Purpose

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.

Condition	Intervention
HIV Infections	Drug: Fat Emulsion 2% Drug: Fat Emulsion 20%

Study Type:	Interventional
Study Design:	Primary Purpose: Treatment
Official Title:	Lipid-Based Parenteral Nutritional Support in Patients With the Acquired Immunodeficiency Syndrome and Pneumocystis Carinii Pneumonia. A Comparison of Two Lipid Formulations

Resource links provided by NLM:

Genetics Home Reference related topics: complement factor I deficiency

MedlinePlus related topics: HIV/AIDS Pneumonia

U.S. FDA Resources

Further study details as provided by Abbott:

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002275

Locations

United States, New Jersey
East Orange Veterans Administration Med Ctr
East Orange, New Jersey, United States, 07018

Sponsors and Collaborators

Abbott

More Information

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.

ClinicalTrials.gov Identifier:	NCT00002275 History of Changes
Other Study ID Numbers:	041B
Study First Received:	November 2, 1999
Last Updated:	February 19, 2009
Health Authority:	United States: Food and Drug Administration

Keywords provided by Abbott:

Weight Loss
Pneumonia, Pneumocystis carinii
Parenteral Nutrition
Liposyn
Acquired Immunodeficiency Syndrome

Additional relevant MeSH terms:

HIV Infections
Acquired Immunodeficiency Syndrome
Immunologic Deficiency Syndromes
Pneumonia
Pneumonia, Pneumocystis
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral

Sexually Transmitted Diseases
Immune System Diseases
Slow Virus Diseases
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Lung Diseases, Fungal
Mycoses
Pneumocystis Infections

ClinicalTrials.gov processed this record on February 12, 2012