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

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002275
• Other study ID #: 041B
• Status: Completed
• Phase: N/A
• First received: November 2, 1999
• Last updated: February 19, 2009

Study information

• Verified date: February 2009
• Source: Abbott
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• Immunologic Deficiency Syndromes
• Pneumonia
• Pneumonia, Pneumocystis

Intervention

Drug:
• Fat Emulsion 2%

• Fat Emulsion 20%

Locations

Country	Name	City	State
United States	East Orange Veterans Administration Med Ctr	East Orange	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Abbott

Country where clinical trial is conducted

United States, 

References & 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. — View Citation