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

NCT ID: NCT00002275

Last Updated: 2009-02-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Brief Summary

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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.

Detailed Description

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Conditions

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HIV Infections

Study Design

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Primary Study Purpose

TREATMENT

Interventions

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Fat Emulsion 2%

Intervention Type DRUG

Fat Emulsion 20%

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Abbott

INDUSTRY

Sponsor Role lead

Locations

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East Orange Veterans Administration Med Ctr

East Orange, New Jersey, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 7993207 (View on PubMed)

Other Identifiers

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041B

Identifier Type: -

Identifier Source: org_study_id

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