NCT00002029

Brief 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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 2, 1999

Completed
1.8 years until next milestone

First Posted

Study publicly available on registry

August 31, 2001

Completed
Last Updated

February 20, 2009

Status Verified

February 1, 2009

First QC Date

November 2, 1999

Last Update Submit

February 19, 2009

Conditions

HIV Infections

Keywords

Weight LossParenteral Nutrition, TotalAIDS-Related Opportunistic InfectionsLiposynAcquired Immunodeficiency Syndrome

Interventions

Fat Emulsion 2%DRUG
Fat Emulsion 20%DRUG

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Intracare Inc

Miami, Florida, 33126, United States

Location

East Orange Veterans Administration Med Ctr

East Orange, New Jersey, 07018, United States

Location

Related Publications (1)

  • Singer P, Rubinstein A, Askanazi J, Calvelli T, Lazarus T, Kirvela 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. doi: 10.1177/0148607192016002165.

    PMID: 1556814BACKGROUND

MeSH Terms

Conditions

HIV InfectionsWeight LossHyperphagiaAIDS-Related Opportunistic InfectionsAcquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesBody Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsSigns and Symptoms, DigestiveOpportunistic InfectionsSlow 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(2)