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

This study has been terminated.

Sponsor:

ClinicalTrials.gov Identifier:

NCT00000961

First Posted: August 31, 2001

Last Update Posted: March 17, 2014

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Collaborators:

Abbott

Glaxo Wellcome

Information provided by:

National Institute of Allergy and Infectious Diseases (NIAID)

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 2


Study Type:	Interventional
Study Design:	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

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS

Drug Information available for: Zidovudine

U.S. FDA Resources

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


Estimated Enrollment:	112
Primary Completion Date:	May 1991 (Final data collection date for primary outcome measure)

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

Information from the National Library of Medicine

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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

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

Publications:

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.


ClinicalTrials.gov Identifier:	NCT00000961 History of Changes
Other Study ID Numbers:	ACTG 131
First Submitted:	November 2, 1999
First Posted:	August 31, 2001
Last Update Posted:	March 17, 2014
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

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