Search / Trial NCT00000961

The Safety and Effectiveness of Hyperimmune Anti-HIV Intravenous Immunoglobulin (HVIG) Plus Zidovudine in HIV-Infected Infants

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001

Apply for Trial

Trial Information

Current as of December 10, 2023

Terminated

Keywords

Drug Therapy, Combination Zidovudine

Description

HIVIG may be an effective agent that either alone or in combination with AZT will prevent progression of clinical disease. Participants are randomized to receive either oral AZT or HIVIG. Patients may receive treatment for a maximum of 48 weeks. Patients are evaluated during treatment at weeks 2, 4, and every 4 weeks thereafter. Infants who are receiving HIVIG initially are treated with the appropriate age-adjusted dose of oral AZT in addition to HIVIG if they meet clinical disease progression criteria. All participants who have completed 48 weeks of treatment or who are discontinued from ...

Gender

All

Eligibility criteria

  • Inclusion Criteria
  • 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:
  • Allowed:
  • Gammaglobulin, intravenous (IV) or intramuscular (IM).
  • Immunoglobulin, IV (IVIG).
  • Maternal antiretroviral treatment during pregnancy.
  • Exclusion Criteria
  • 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.

Attachments

readout_NCT00000961_2023-12-10.pdf

4.5 MB

NCT00000961_study_protocol.pdf

4.5 MB

About company

The National Institute of Allergy and Infectious Diseases (NIAID, /ˈnaɪ.æd/) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services (HHS). NIAID's mission is to conduct basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases.

Contacts

JC

Jennifer Cobb

Immunology at National Institute of Allergy and Infectious Diseases (NIAID)

Locations

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Reviews (48)

4.6

All reviews come from applied patients

5 stars
41
4 stars
6
3 stars
2
2 stars
0
1 stars
0
Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Michael Foster
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Dries Vincent
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Discussion 0