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HIV InfectionsPhase 3NCT00000720

A Double-Blind, Placebo-Controlled Trial To Evaluate Intravenous Gamma Globulin in Children With Symptomatic HIV Infection Receiving Zidovudine

A Phase 3 study testing Globulin, Immune and Zidovudine in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 51 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

To evaluate the clinical, immunologic, and virologic effects of oral zidovudine (AZT) plus intravenous immunoglobulin (IVIG) versus AZT plus placebo (albumin). It is estimated that by 1991, there may be 10,000 to 20,000 HIV-infected children in the United States. Read more about this study

Who is it for?
Ages 3 months to 12 years
Conditions the study is for
HIV Infections
What is being tested?
Globulin, Immune and Zidovudine
How many people
250 participants
Where
51 sitesin 2 countries
Study dates
Start not givento Apr 1993
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 3 months to 12 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Concurrent Medication:
  • Allowed:
  • Benadryl and/or acetaminophen may be given before and during intravenous immunoglobulin (IVIG) infusion in patients demonstrating mild reactions during infusion.
  • Acetaminophen for short-term fever and pain.
  • Zidovudine (AZT).
  • Steroids.
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  • Oral or systemic (swish and swallow) nystatin.
  • Maintenance therapy for fungal disease or tuberculosis.
  • Prophylaxis for a previous episode of Pneumocystis carinii pneumonia (PCP) including the use of trimethoprim / sulfamethoxazole (TMP / SMX). The dosage is specified as TMP 75 mg/m2 twice daily 3 times a week and SMX 375 mg/m2 twice daily 3 times a week.
  • Recommended:
  • Children with AIDS and / or CD4 count = or < 500 cells/mm3 should receive primary PCP prophylaxis as described.
  • Concurrent Treatment:
  • Allowed:
  • Blood transfusion for hemoglobin < 8 g/dl and hematocrit < 24 percent or bone marrow suppression.
  • Supplemental oxygen with a prestudy PaO2 < 70 mmHg.
  • Children must have one or more of the indicator diseases of AIDS; however, there must be an absence of acute opportunistic infection and an absence of bacterial infection requiring treatment at the time of entry into the study.
  • Children with lymphoid interstitial proliferation (LIP) are excluded from enrollment unless they have had additional AIDS-defining opportunistic infections, meet ARC criteria, have had two or more serious bacterial infections in the 12 months prior to study entry, have evidence of HIV encephalopathy, or are currently on supplemental oxygen and steroids with a pre-treatment PaO2 < 70 mm Hg.
  • Children with concurrent LIP and ARC are eligible for inclusion. Thrombocytopenia is an exclusion except if it is HIV-associated.
  • Children randomized prior to their 13th birthday are eligible.
  • All lab values must be within 4 weeks of study entry.
  • Prior Medication:
  • Allowed:
  • Zidovudine (AZT).

Who cannot join

  • Co-existing Condition:
  • Patients with the following will be excluded:
  • Lymphoid interstitial proliferation (LIP) not requiring steroids and supplemental oxygen or with other lymphoproliferative diseases as their sole clinical evidence of HIV infection.
  • Known hypersensitivity to immunoglobulin.
  • Active HIV thrombocytopenia requiring IVIG therapy.
  • Concurrent Medication:
Show all 26Show fewer
  • Excluded:
  • Chronic acetaminophen.
  • Drugs that are metabolized by hepatic glucuronidation should not be used for more than 24 hours without notifying the study physician.
  • Antibacterial prophylaxis for otitis, sinusitis, or urinary tract infection.
  • Prophylaxis treatment for Pneumocystis carinii pneumonia (PCP) prior to the first episode of laboratory-documented PCP.
  • Immunoglobulin (IVIG) therapy required for active HIV thrombocytopenia.
  • Patients with the following will be excluded:
  • Lymphoid interstitial proliferation (LIP) not requiring steroids and supplemental oxygen or with other lymphoproliferative diseases as their sole clinical evidence of HIV infection.
  • Known hypersensitivity to immunoglobulin.
  • Active HIV thrombocytopenia requiring IVIG therapy.
  • Inability to establish or maintain intravenous access.
  • Lack of parental or guardian authorization for intravenous access.
  • Prior Medication:
  • Excluded within 4 weeks of study entry:
  • Any other experimental therapy.
  • Other antiretroviral agents.
  • Drugs which cause prolonged neutropenia or significant nephrotoxicity.
  • Immunoglobulins.
  • Immunomodulating agents.
  • Active alcohol or drug abuse.

Trial locations and contacts

51 sites in 2 countries.

51 sites in 2 countries

United States48 sites

  • Emory Univ School of Medicine

    Atlanta, Georgia, 30303

  • Univ of Maryland at Baltimore / Univ Med Ctr

    Baltimore, Maryland, 21201

  • Children's Hosp of Boston

    Boston, Massachusetts, 021155724

  • Boston Med Ctr

    Boston, Massachusetts, 02118

  • SUNY / Health Sciences Ctr at Brooklyn / Pediatrics

    Brooklyn, New York, 11203

  • Cook County Hosp

    Chicago, Illinois, 60612

  • Univ of Illinois College of Medicine

    Chicago, Illinois, 60612

  • Chicago Children's Memorial Hosp

    Chicago, Illinois, 606143394

  • Holmes Hosp / Univ of Cincinnati Med Ctr

    Cincinnati, Ohio, 452670405

  • Univ Hosp of Cleveland / Case Western Reserve Univ

    Cleveland, Ohio, 44106

  • Columbus Children's Hosp

    Columbus, Ohio, 432052696

  • Ohio State Univ Hosp Clinic

    Columbus, Ohio, 432101228

  • Kaiser Permanente / UCLA Med Ctr

    Downey, California, 902422814

  • Duke Univ Med Ctr

    Durham, North Carolina, 277103499

  • City Hosp Ctr at Elmhurst / Mount Sinai Hosp

    Elmhurst, New York, 11373

  • Univ of Connecticut Health Ctr / Pediatrics

    Farmington, Connecticut, 06032

  • Hermann Hosp / Univ Texas Health Science Ctr

    Houston, Texas, 77030

  • Texas Children's Hosp / Baylor Univ

    Houston, Texas, 77030

  • Long Beach Memorial (Pediatric)

    Long Beach, California, 90801

  • Children's Hosp of Los Angeles/UCLA Med Ctr

    Los Angeles, California, 900276016

  • Los Angeles County - USC Med Ctr

    Los Angeles, California, 90033

  • Cedars Sinai / UCLA Med Ctr

    Los Angeles, California, 900481804

  • Martin Luther King Jr Gen Hosp / UCLA Med Ctr

    Los Angeles, California, 900593019

  • UCLA Med Ctr / Pediatric

    Los Angeles, California, 900951752

  • Stanford Univ School of Medicine

    Menlo Park, California, 94025

  • Univ of Minnesota

    Minneapolis, Minnesota, 55455

  • Schneider Children's Hosp / Long Island Jewish Med Ctr

    New Hyde Park, New York, 11042

  • Tulane Univ School of Medicine

    New Orleans, Louisiana, 70112

  • Beth Israel Med Ctr / Pediatrics

    New York, New York, 10003

  • Bellevue Hosp / New York Univ Med Ctr

    New York, New York, 10016

  • Saint Luke's - Roosevelt Hosp Ctr

    New York, New York, 10025

  • Metropolitan Hosp Ctr

    New York, New York, 10029

  • Mount Sinai Med Ctr

    New York, New York, 10029

  • Columbia Univ Babies' Hosp

    New York, New York, 10032

  • Harlem Hosp Ctr

    New York, New York, 10037

  • Children's Hosp of New Jersey / UMDNJ - New Jersey Med Schl

    Newark, New Jersey, 071072198

  • Children's Hosp of Oakland

    Oakland, California, 946091809

  • Saint Christopher's Hosp for Children

    Philadelphia, Pennsylvania, 191341095

  • Univ of Rochester Medical Center

    Rochester, New York, 14642

  • Univ of California / San Diego Treatment Ctr

    San Diego, California, 921036325

  • Northern California Pediatric AIDS Treatment Ctr / UCSF

    San Francisco, California, 94143

  • Children's Hosp of Seattle

    Seattle, Washington, 98105

  • Olive View Med Ctr

    Sylmar, California, 91342

  • Lincoln Hosp Ctr / Pediatrics

    The Bronx, New York, 10451

  • Albert Einstein College of Medicine

    The Bronx, New York, 10461

  • Westchester Hosp / New York Med College / Pediatrics

    Valhalla, New York, 10595

  • Julio Arroyo

    West Columbia, South Carolina, 29169

  • Univ of Massachusetts Med Ctr

    Worcester, Massachusetts, 01655

Other trials in United States

Puerto Rico3 sites

  • Ramon Ruiz Arnau Univ Hosp / Pediatrics

    Bayamón, 00619

  • San Juan City Hosp

    San Juan, 009367344

  • UPR Children's Hosp / San Juan City Hosp

    San Juan, 00936

Other trials in Puerto Rico

About this study

To evaluate the clinical, immunologic, and virologic effects of oral zidovudine (AZT) plus intravenous immunoglobulin (IVIG) versus AZT plus placebo (albumin). It is estimated that by 1991, there may be 10,000 to 20,000 HIV-infected children in the United States. HIV infection in children is most often associated with symptomatic disease and poor prognosis. Treatment with antiviral therapy may be effective in changing the course of disease and decreasing mortality in this vulnerable population. AZT treatment has been shown to decrease mortality and the frequency of opportunistic infections in certain adult AIDS patients; therefore, it is likely that children may also benefit from this antiviral therapy. In addition, bacterial infections are frequently found in HIV-infected children. Because pooled human serum immunoglobulin, another name for antibodies, is effective in reducing bacterial infection in patients with defects of immunity, it may reduce the rate of bacterial infection in HIV-infected children as well. In this study, AZT will be administered together with IVIG to determine safety, tolerance, and efficacy of the combined treatment.

Read the detailed description

It is estimated that by 1991, there may be 10,000 to 20,000 HIV-infected children in the United States. HIV infection in children is most often associated with symptomatic disease and poor prognosis. Treatment with antiviral therapy may be effective in changing the course of disease and decreasing mortality in this vulnerable population. AZT treatment has been shown to decrease mortality and the frequency of opportunistic infections in certain adult AIDS patients; therefore, it is likely that children may also benefit from this antiviral therapy. In addition, bacterial infections are frequently found in HIV-infected children. Because pooled human serum immunoglobulin, another name for antibodies, is effective in reducing bacterial infection in patients with defects of immunity, it may reduce the rate of bacterial infection in HIV-infected children as well. In this study, AZT will be administered together with IVIG to determine safety, tolerance, and efficacy of the combined treatment.

The study includes 250 children, 3 months to 12 years of age. All participants receive oral AZT. IVIG or intravenous placebo is administered every 28 days. Patients are followed for the development of serious bacterial infection, as well as for a number of factors relating to safety, tolerance, progression of disease, and survival. This is an outpatient study conducted over a minimum 100-week period. The children are evaluated every 2 weeks for the first 8 weeks, and monthly thereafter.

Conditions
HIV Infections
Being tested
Globulin, Immune, Zidovudine
Keywords
AIDS-Related Opportunistic Infections, Placebos, Infusions, Intravenous, Gamma-Globulins, Combined Modality Therapy, Acquired Immunodeficiency Syndrome, Zidovudine, Bacterial Infections, Immunization, Passive
Medical subject headings
HIV Infections, AIDS-Related Opportunistic Infections, Acquired Immunodeficiency Syndrome, Bacterial Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Aug 2001 (estimated)
  2. Study completionApr 1993

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Masking
Double blind
Enrolment
250 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00000720
Sponsor's protocol ID
ACTG 051
Other IDs
11025
Status last verified
Oct 2021
First submitted
2 Nov 1999
Last updated
3 Nov 2021
Results posted
No

Publications

  • Connor E, McSherry G. Treatment of HIV infection in infancy. Clin Perinatol. 1994 Mar;21(1):163-77.

    PubMed 7912175

  • Mofenson LM, Moye J Jr. Intravenous immune globulin for the prevention of infections in children with symptomatic human immunodeficiency virus infection. Pediatr Res. 1993 Jan;33(1 Suppl):S80-7; discussion S87-9. doi: 10.1203/00006450-199305001-00464.

    PubMed 8433880

  • Perrier M, Schwarz T, Gonzalez O, Brounts S. Squamous cell carcinoma invading the right temporomandibular joint in a Belgian mare. Can Vet J. 2010 Aug;51(8):885-7.

    PubMed 21037891

  • Spector SA, Gelber RD, McGrath N, Connor EM, Wara DW, Balsley JF. Results of a double-blind placebo-controlled trial to evaluate intravenous gamma globulin in children with symptomatic HIV infection receiving zidovudine (ACTG 051). The Pediatric AIDS Clinical Trials Group and the NICHD Pediatric HIV Centers. Int Conf AIDS. 1993 Jun 6-11;9(1):48 (abstract no WS-B05-6)

  • 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. doi: 10.1056/NEJM199411033311802.

    PubMed 7935655

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Globulin, Immune and Zidovudine in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 51 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 23 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 51 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00000720, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2021.

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