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

Tracking Information
First Received Date ^ICMJE	November 2, 1999
Last Updated Date	February 19, 2009
Start Date ^ICMJE
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00002036 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Phase I Safety Study of Anti-HIV Immune Serum Globulin (Human)
Official Title ^ICMJE	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 ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Safety Study
Condition ^ICMJE	HIV Infections
Intervention ^ICMJE	Drug: Anti-HIV Immune Serum Globulin (Human)
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	12
Completion Date
Primary Completion Date
Eligibility Criteria ^ICMJE	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 ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00002036
Responsible Party
Study ID Numbers ^ICMJE	060A, 0001-008
Study Sponsor ^ICMJE	Abbott
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Abbott
Verification Date	February 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP