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

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

This study has been completed.

Study NCT00002036. Last updated on June 23, 2005. Information provided by NIH AIDS Clinical Trials Information Service

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields
Brief Title ^†	Phase I Safety Study of Anti-HIV Immune Serum Globulin (Human)
Official Title ^†	Phase I Safety Study of Anti-HIV Immune Serum Globulin (Human)
Brief Summary	To investigate the potential benefit of providing passive immunity with hyperimmune anti-HIV human serum.
Detailed Description
Study Phase	Phase I
Study Type ^†	Interventional
Study Design ^†	Treatment, Safety Study
Primary Outcome Measure ^†
Secondary Outcome Measure ^†
Condition ^†	HIV Infections
Intervention ^†	Drug: Anti-HIV Immune Serum Globulin (Human)
MEDLINE PMIDs
Links

Recruitment Information Fields
Recruitment Status ^†	Completed
Enrollment ^†	12
Start Date ^†
Completion Date
Eligibility 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.
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^††
Location Countries ^†	United States

Administrative Information Fields
NCT ID ^†	NCT00002036
Organization ID	060A
Secondary IDs ^††	0001-008
Study Sponsor ^†	Abbott
Collaborators ^††
Investigators ^†
Information Provided By	NIH AIDS Clinical Trials Information Service
Verification Date	February 1990
First Received Date ^†	November 2, 1999
Last Updated Date	June 23, 2005

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.