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

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

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