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The Safety and Effectiveness of Hyperimmune Anti-HIV Intravenous Immunoglobulin (HVIG) Plus Zidovudine in HIV-Infected Infants
This study has been terminated.
Sponsors and Collaborators: National Institute of Allergy and Infectious Diseases (NIAID)
Abbott
Glaxo Wellcome
Information provided by: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00000961
  Purpose

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.


Condition Intervention Phase
HIV Infections
Drug: Anti-HIV Immune Serum Globulin (Human)
Drug: Zidovudine
Phase II

MedlinePlus related topics: AIDS
Drug Information available for: Zidovudine Immunoglobulins Globulin, Immune
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Parallel Assignment, Safety Study
Official Title: A Phase II Study to Evaluate the Safety, Tolerance and Efficacy of Hyperimmune Anti-HIV Intravenous Immunoglobulin (HIVIG) and of Zidovudine (ZDV) in Infants With Documented HIV Infections

Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Estimated Enrollment: 112
Detailed 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 treatment are followed every 3 months for an additional 48 weeks. This follow-up may be conducted over the telephone.

  Eligibility

Ages Eligible for Study:   up to 3 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00000961

Sponsors and Collaborators
Abbott
Glaxo Wellcome
Investigators
Study Chair: Connor E
  More Information

Click here for more information about Zidovudine  This link exits the ClinicalTrials.gov site

Publications:
Study ID Numbers: ACTG 131
Study First Received: November 2, 1999
Last Updated: August 1, 2008
ClinicalTrials.gov Identifier: NCT00000961  
Health Authority: United States: Federal Government

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Drug Therapy, Combination
Zidovudine

Study placed in the following topic categories:
Sexually Transmitted Diseases, Viral
Acquired Immunodeficiency Syndrome
Zidovudine
Immunologic Deficiency Syndromes
Immune Sera
Virus Diseases
Antibodies
HIV Infections
Immunoglobulins, Intravenous
Sexually Transmitted Diseases
Rho(D) Immune Globulin
Retroviridae Infections
Immunoglobulins

Additional relevant MeSH terms:
Antimetabolites
Anti-Infective Agents
Communicable Diseases
RNA Virus Infections
Anti-HIV Agents
Slow Virus Diseases
Immune System Diseases
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Enzyme Inhibitors
Infection
Antiviral Agents
Pharmacologic Actions
Reverse Transcriptase Inhibitors
Anti-Retroviral Agents
Therapeutic Uses
Lentivirus Infections
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on January 15, 2009