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

NCT00002275 | Completed

• 1 other identifier: 041B
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV Infections

Keywords

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

Interventions

Fat Emulsion 2% DRUG

Fat Emulsion 20% DRUG

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Abbott: lead

Study Sites (1)

East Orange Veterans Administration Med Ctr

East Orange, New Jersey, 07018, United States

Location

Related Publications (1)

• 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.

  PMID: 7993207 BACKGROUND

MeSH Terms

Conditions

HIV Infections; Weight Loss; Pneumonia, Pneumocystis; Hyperphagia; Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Purpose: TREATMENT
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 2, 1999
• First Posted: August 31, 2001
• Last Updated: February 20, 2009

Record last verified: 2009-02

Locations

US (1)