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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

HIV Infections Acquired Immunodeficiency Syndrome Bacterial Infections and Mycoses Blood-Borne Infections Body Weight Body Weight Changes Communicable Diseases Genital Diseases Hyperphagia Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Lung Diseases Lung Diseases, Fungal Mycoses Pathological Conditions, Signs and Symptoms Pneumocystis Infections Pneumonia Pneumonia, Pneumocystis RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Signs and Symptoms Signs and Symptoms, Digestive Slow Virus Diseases Urogenital Diseases Virus Diseases Weight Loss

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

East Orange Veterans Administration Med Ctr

East Orange, New Jersey, 07018, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fat Emulsion 2%

Drug

Fat Emulsion 20%

Drug

Sponsors and collaborators

Lead sponsor

Abbott

Industry

Registry information

Official study title

Lipid-Based Parenteral Nutritional Support in Patients With the Acquired Immunodeficiency Syndrome and Pneumocystis Carinii Pneumonia. A Comparison of Two Lipid Formulations

Important dates

First posted: Aug 31, 2001
Registry last updated: Feb 20, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed