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

Abbott

Status and phase: Completed; Phase 1

Conditions: HIV Infections

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00002036

060A

0001-008

Details and patient eligibility

About

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

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.