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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00002036
First Posted: August 31, 2001
Last Update Posted: February 20, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Abbott
  Purpose
To investigate the potential benefit of providing passive immunity with hyperimmune anti-HIV human serum.

Condition Intervention Phase
HIV Infections Drug: Anti-HIV Immune Serum Globulin (Human) Phase 1

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Phase I Safety Study of Anti-HIV Immune Serum Globulin (Human)

Resource links provided by NLM:


Further study details as provided by Abbott:

Estimated Enrollment: 12
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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.

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002036


Locations
United States, Minnesota
Univ of Minnesota
Minneapolis, Minnesota, United States, 55455
Sponsors and Collaborators
Abbott
  More Information

ClinicalTrials.gov Identifier: NCT00002036     History of Changes
Other Study ID Numbers: 060A
0001-008
First Submitted: November 2, 1999
First Posted: August 31, 2001
Last Update Posted: February 20, 2009
Last Verified: February 2009

Keywords provided by Abbott:
Acquired Immunodeficiency Syndrome
AIDS-Related Complex
Immunization, Passive

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Immune Sera
Immunologic Factors
Physiological Effects of Drugs