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

Sponsor:	Abbott
Information provided by:	Abbott
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

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:

MedlinePlus related topics: AIDS

U.S. FDA Resources

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

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

Keywords provided by Abbott:

Acquired Immunodeficiency Syndrome
AIDS-Related Complex
Immunization, Passive

Additional relevant MeSH terms:

RNA Virus Infections
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Immune System Diseases
Immunologic Factors
Physiological Effects of Drugs
Acquired Immunodeficiency Syndrome
Pharmacologic Actions

Immunologic Deficiency Syndromes
Immune Sera
Virus Diseases
HIV Infections
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections

ClinicalTrials.gov processed this record on March 18, 2010