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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00002029
Other study ID # 041A
Secondary ID
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

To compare two lipid emulsions in the long-term parenteral alimentation of patients with AIDS in relation to: Clinical effectiveness. Effect on immunologic function. Effect on HIV load as measured by p24 antigen levels. Effect on relative HIV infectivity.


Recruitment information / eligibility

Status Completed
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria

Concurrent Medication:

Allowed:

- Zidovudine (AZT).

- All drugs used for the standard treatment of opportunistic infections.

- Other drugs used for the 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 of > 10 percent premorbid body weight.

- Presenting diagnosis of either opportunistic infection or Kaposi's sarcoma.

- Require home total parenteral nutrition (TPN) for a period of approximately 3 months.

- Life expectancy = or > 90 days.

Prior Medication:

Allowed:

- Zidovudine (AZT).

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions or symptoms are excluded:

- Life expectancy < 90 days.

- Biliary stasis.

- History of drug abuse.

Patients with the following are excluded:

- Life expectancy < 90 days.

- Biliary stasis.

- History of drug abuse.

Prior Medication:

Excluded within 3 months of study entry:

- Immunomodulators.

- Experimental antiviral DT. History of drug abuse.

Study Design

Primary Purpose: Treatment


Related Conditions & MeSH terms


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
United States Intracare Inc Miami Florida

Sponsors (1)

Lead Sponsor Collaborator
Abbott

Country where clinical trial is conducted

United States, 

References & Publications (1)

Singer P, Rubinstein A, Askanazi J, Calvelli T, Lazarus T, Kirvelä O, Katz DP. Clinical and immunologic effects of lipid-based parenteral nutrition in AIDS. JPEN J Parenter Enteral Nutr. 1992 Mar-Apr;16(2):165-7. — View Citation

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