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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Abbott
• Treatments: Immune Sera

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.