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

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ClinicalTrials.gov Identifier: NCT00000961
Recruitment Status : Terminated
First Posted : August 31, 2001
Last Update Posted : March 14, 2011
Sponsor:
Collaborators:
Abbott
Glaxo Wellcome
Information provided by:
National Institute of Allergy and Infectious Diseases (NIAID)

Study Description
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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.

Condition or disease Intervention/treatment Phase
HIV Infections Drug: Anti-HIV Immune Serum Globulin (Human) Drug: Zidovudine Phase 2

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.


Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 112 participants
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
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
Actual Primary Completion Date : May 1991

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
Drug Information available for: Zidovudine
U.S. FDA Resources

Arms and Interventions
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Outcome Measures
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Eligibility Criteria
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Ages Eligible for Study:   up to 3 Months   (Child)
Sexes Eligible for Study:   All
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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00000961


Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Abbott
Glaxo Wellcome
Investigators
Study Chair: Connor E
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications:

ClinicalTrials.gov Identifier: NCT00000961     History of Changes
Other Study ID Numbers: ACTG 131
First Posted: August 31, 2001    Key Record Dates
Last Update Posted: March 14, 2011
Last Verified: March 1998

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

Additional relevant MeSH terms:
Infection
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Zidovudine
Immunoglobulins
Antibodies
 Immunoglobulins, Intravenous
gamma-Globulins
Rho(D) Immune Globulin
Immune Sera
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Anti-HIV Agents
Immunologic Factors
Physiological Effects of Drugs