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

NCT ID: NCT00002036

Last Updated: 2009-02-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL

Brief Summary

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

Conditions

HIV Infections

Study Design

• Primary Study Purpose: TREATMENT

Interventions

Anti-HIV Immune Serum Globulin (Human)

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abbott

INDUSTRY

Sponsor Role: lead

Locations

Univ of Minnesota

Minneapolis, Minnesota, United States

Countries

United States

Other Identifiers

0001-008

Identifier Type: -

Identifier Source: secondary_id

060A

Identifier Type: -

Identifier Source: org_study_id