Completed

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

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What is being tested

Anti-HIV Immune Serum Globulin (Human)

Drug
Who is being recruted

Blood-Borne Infections+14

+ Urogenital Diseases

+ Genital Diseases

Over 18 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1
Interventional
See protocol details

Summary

Principal SponsorAbbott
Last updated: February 20, 2009
Sourced from a government-validated database.Claim as a partner

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

NCT00002036
Principal SponsorAbbott
Last updated: February 20, 2009
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

12 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Blood-Borne InfectionsUrogenital DiseasesGenital DiseasesCommunicable DiseasesImmunologic Deficiency SyndromesImmune System DiseasesInfectionsRetroviridae InfectionsRNA Virus InfectionsSexually Transmitted DiseasesSlow Virus DiseasesVirus DiseasesSexually Transmitted Diseases, ViralLentivirus InfectionsAcquired Immunodeficiency SyndromeAIDS-Related ComplexHIV Infections

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.

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Univ of Minnesota

Minneapolis, United StatesOpen Univ of Minnesota in Google Maps
CompletedOne Study Center