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

Abbott

Status: Completed

Conditions: HIV Infections

Treatments: Drug: Fat Emulsion 20%; Drug: Fat Emulsion 2%

Study type: Interventional

Funder types: Industry

Identifiers

NCT00002275

041B

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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