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

This study has been completed.

Sponsored by: Abbott
Information provided by: NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier: NCT00002036
  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 I

MedlinePlus related topics:   AIDS   

U.S. FDA Resources

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

Further study details as provided by NIH AIDS Clinical Trials Information Service:

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


Study ID Numbers:   060A, 0001-008
First Received:   November 2, 1999
Last Updated:   June 23, 2005
ClinicalTrials.gov Identifier:   NCT00002036
Health Authority:   United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:
Acquired Immunodeficiency Syndrome  
AIDS-Related Complex  
Immunization, Passive  

Study placed in the following topic categories:
Virus Diseases
Sexually Transmitted Diseases, Viral
HIV Infections
Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
AIDS-Related Complex
Retroviridae Infections
Immune Sera
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:
RNA Virus Infections
Slow Virus Diseases
Immunologic Factors
Immune System Diseases
Physiological Effects of Drugs
Lentivirus Infections
Infection
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 30, 2008




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