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

This study has been completed.
Information provided by:
Abbott Identifier:
First received: November 2, 1999
Last updated: February 19, 2009
Last verified: February 2009
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

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   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

Co-existing Condition:

Patients with the following conditions or symptoms are excluded:

  • HIV-induced neurological disease.
  • IgA negative.

Concurrent Medication:


  • 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
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00002036

United States, Minnesota
Univ of Minnesota
Minneapolis, Minnesota, United States, 55455
Sponsors and Collaborators
  More Information Identifier: NCT00002036     History of Changes
Other Study ID Numbers: 060A
Study First Received: November 2, 1999
Last Updated: February 19, 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 processed this record on September 20, 2017