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CompletedNCT00002036Updated Feb 20, 2009

Phase I Safety Study of Anti-HIV Immune Serum Globulin (Human)

A Phase 1 interventional study of Anti-HIV Immune Serum Globulin (Human) in HIV Infections, sponsored by Abbott. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2009-02-20.

Sponsored by Abbott · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
12
Ages
18 Years and older
Sex
All
01

Study summary

To investigate the potential benefit of providing passive immunity with hyperimmune anti-HIV human serum.

02

Conditions studied

  • HIV Infections

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Keywords

  • Acquired Immunodeficiency Syndrome
  • AIDS-Related Complex
  • Immunization, Passive
03

In context

HIV Infections

4,258 studies on the registry are indexed under HIV Infections; 240 are open to participants now.

This study's enrollment of 12 is below the median of 83 across 3,251 interventional studies indexed under HIV Infections.

Browse HIV Infections studies →

Lead sponsor

Abbott is the lead sponsor of 350 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

Patients must have:

  • Proof of HIV infection.
  • Diagnosis of asymptomatic HIV infection or early AIDS related complex (ARC) with no zidovudine (AZT) or other anti-HIV therapy. OR a diagnosis of AIDS and = or > 3 months of AZT therapy.

Exclusion criteria

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions or symptoms are excluded:

  • HIV-induced neurological disease.
  • IgA negative.

Concurrent Medication:

Excluded:

  • Immunomodulating agents.
  • Steroids.
  • Interferons.

Patients with the following are excluded:

  • Active substance abuse.
  • Use of immunomodulating drugs such as steroids or interferons.
  • HIV-induced neurological disease.
  • IgA negative.

Required with a diagnosis of AIDS:

  • = or > 3 months of zidovudine (AZT) therapy.

Active substance abuse.

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Enrollment
12 participants

Interventions

  • DrugAnti-HIV Immune Serum Globulin (Human)
06

Study locations

1 site
  • Univ of Minnesota
    Minneapolis, Minnesota 55455, United States
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 20, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT00002036
Lead sponsor
Abbott
First posted
Aug 31, 2001
Last update
Feb 20, 2009
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2009. You cannot join it, but the record below documents what was studied.

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