NCT00000961

Brief Summary

To determine the safety and tolerance of hyperimmune anti-HIV intravenous immunoglobulin (HIVIG) and of zidovudine (AZT) in infants with established HIV infection; to get preliminary evidence for the effectiveness of this type of treatment in preventing the advance of disease in HIV infected infants. HIVIG may be an effective agent that either alone or in combination with AZT will prevent progression of clinical disease.

Trial Health

10
At Risk

Trial Health Score

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

Enrollment
112

participants targeted

Target at P50-P75 for phase_2 hiv-infections

Status
terminated

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Primary Completion

Last participant's last visit for primary outcome

May 1, 1991

Completed
8.5 years until next milestone

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

November 4, 2021

Status Verified

October 1, 2021

First QC Date

November 2, 1999

Last Update Submit

October 28, 2021

Conditions

HIV Infections

Keywords

Drug Therapy, CombinationZidovudine

Interventions

Anti-HIV Immune Serum Globulin (Human)DRUG
ZidovudineDRUG

Eligibility Criteria

Age1 Day - 3 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Concurrent Medication:
  • Allowed:
  • Recommended:
  • Standard immunizations. Should repeat MMR 3 months after discontinuing study.
  • Benadryl and/or aspirin.
  • Pneumocystis carinii pneumonia prophylaxis.
  • Systemic ketoconazole and acyclovir, or oral nystatin for acute therapy.
  • Aerosol ribavirin for short-term treatment of RSV.
  • Concurrent Treatment:
  • Allowed:
  • Blood transfusion.
  • Patients must have the following:
  • Parent or guardian available to give written informed consent.
  • Protocol requires prior Institutional Review Board (IRB) approval before any subject is entered into study.
  • Prior Medication:
  • +4 more criteria

You may not qualify if:

  • Co-existing Condition:
  • Patients with the following conditions or symptoms are excluded:
  • Symptomatic of any class P-2 symptoms (except lymphadenopathy at time of study entry.
  • Presence of serious acute infection requiring parenteral treatment at time of study entry.
  • Concurrent Medication:
  • Excluded:
  • Prophylaxis for oral candidiasis or otitis media or other infections.
  • Immunoglobulin therapy (except single dose or for hypogammaglobulinemia).
  • Ketoconazole, acyclovir, or nystatin for prophylaxis.
  • Patients with the following are excluded:
  • Symptomatic of any class P-2 symptoms (except lymphadenopathy at time of study entry.
  • Presence of serious acute infection requiring parenteral treatment at time of study entry.
  • Prior Medication:
  • Excluded:
  • Antiretroviral treatment or experimental treatment within 2 weeks of entry.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Spector SA, Gelber RD, McGrath N, Wara D, Barzilai A, Abrams E, Bryson YJ, Dankner WM, Livingston RA, Connor EM. A controlled trial of intravenous immune globulin for the prevention of serious bacterial infections in children receiving zidovudine for advanced human immunodeficiency virus infection. Pediatric AIDS Clinical Trials Group. N Engl J Med. 1994 Nov 3;331(18):1181-7. doi: 10.1056/NEJM199411033311802.

    PMID: 7935655BACKGROUND

MeSH Terms

Conditions

HIV Infections

Interventions

Zidovudine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

ThymidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsDideoxynucleosidesDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and Nucleosides

Study Officials

  • Connor E

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH

Study Record Dates

First Submitted

November 2, 1999

First Posted

August 31, 2001

Primary Completion

May 1, 1991

Last Updated

November 4, 2021

Record last verified: 2021-10