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

This study has been terminated.
Sponsor:
Collaborators:
Abbott
Glaxo Wellcome
Information provided by:
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00000961
First received: November 2, 1999
Last updated: March 11, 2011
Last verified: March 1998

November 2, 1999
March 11, 2011
Not Provided
May 1991   (final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT00000961 on ClinicalTrials.gov Archive Site
Not Provided
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The Safety and Effectiveness of Hyperimmune Anti-HIV Intravenous Immunoglobulin (HVIG) Plus Zidovudine in HIV-Infected Infants
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

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.

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.

Interventional
Phase 2
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
HIV Infections
  • Drug: Anti-HIV Immune Serum Globulin (Human)
  • Drug: Zidovudine
Not Provided
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
112
Not Provided
May 1991   (final data collection date for primary outcome measure)

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.
Both
up to 3 Months
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00000961
ACTG 131
Not Provided
Not Provided
National Institute of Allergy and Infectious Diseases (NIAID)
  • Abbott
  • Glaxo Wellcome
Study Chair: Connor E
National Institute of Allergy and Infectious Diseases (NIAID)
March 1998

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP