search
Back to results

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

Primary Purpose

HIV Infections

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Anti-HIV Immune Serum Globulin (Human)
Sponsored by
Abbott
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Immunization, Passive

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Univ of Minnesota

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
February 19, 2009
Sponsor
Abbott
search

1. Study Identification

Unique Protocol Identification Number
NCT00002036
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)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2009
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Abbott

4. Oversight

5. Study Description

Brief Summary
To investigate the potential benefit of providing passive immunity with hyperimmune anti-HIV human serum.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Immunization, Passive

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Enrollment
12 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Anti-HIV Immune Serum Globulin (Human)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Univ of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs