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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00002036

Enrollment

Registered

2001-08-31

Start date

Unknown

Completion date

Unknown

Last updated

2009-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infections

Keywords

Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Immunization, Passive

Brief summary

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

Interventions

DRUGAnti-HIV Immune Serum Globulin (Human)

Study design

Primary purpose

TREATMENT

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026