NCT00002036

Brief Summary

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

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_1 hiv-infections

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 2, 1999

Completed
1.8 years until next milestone

First Posted

Study publicly available on registry

August 31, 2001

Completed
Last Updated

February 20, 2009

Status Verified

February 1, 2009

First QC Date

November 2, 1999

Last Update Submit

February 19, 2009

Conditions

HIV Infections

Keywords

Acquired Immunodeficiency SyndromeAIDS-Related ComplexImmunization, Passive

Interventions

Anti-HIV Immune Serum Globulin (Human)DRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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:
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Univ of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

HIV InfectionsAcquired Immunodeficiency SyndromeAIDS-Related Complex

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesSlow Virus Diseases

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 2, 1999

First Posted

August 31, 2001

Last Updated

February 20, 2009

Record last verified: 2009-02

Locations

US(1)