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

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002036
• Other study ID #: 060A
• Secondary ID: 0001-008
• Status: Completed
• Phase: Phase 1
• First received: November 2, 1999
• Last updated: February 19, 2009

Study information

• Verified date: February 2009
• Source: Abbott
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Safety Study, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infections

Intervention

Drug:
• Anti-HIV Immune Serum Globulin (Human)

Locations

Country	Name	City	State
United States	Univ of Minnesota	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Abbott

Country where clinical trial is conducted

United States,