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

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

Completed

Looking for future studies?

Key information

Conditions

HIV Infections AIDS-Related Complex Acquired Immunodeficiency Syndrome Blood-Borne Infections Communicable Diseases Genital Diseases Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Univ of Minnesota

Minneapolis, Minnesota, 55455, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Anti-HIV Immune Serum Globulin (Human)

Drug

Sponsors and collaborators

Lead sponsor

Abbott

Industry

Registry information

Important dates

First posted: Aug 31, 2001
Registry last updated: Feb 20, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed