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

This study has been completed.
Sponsor:
Information provided by:
Abbott
ClinicalTrials.gov Identifier:
NCT00002036
First received: November 2, 1999
Last updated: February 19, 2009
Last verified: February 2009
  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: Endpoint Classification: Safety Study
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002036

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

No publications provided

ClinicalTrials.gov Identifier: NCT00002036     History of Changes
Other Study ID Numbers: 060A, 0001-008
Study First Received: November 2, 1999
Last Updated: February 19, 2009
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on April 16, 2014