A Double-Blind, Placebo-Controlled Trial To Evaluate Intravenous Gamma Globulin in Children With Symptomatic HIV Infection Receiving Zidovudine
Public ClinicalTrials.gov record NCT00000720. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT00000720
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 250 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 3 Months to 12 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Not listed
- Primary completion
- Not listed
- Completion
- Apr 1993 (Actual)
- Last update posted
- Nov 3, 2021
Ends 1993
United States locations
- U.S. sites
- 48
- U.S. states
- 16
- U.S. cities
- 32
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Kaiser Permanente / UCLA Med Ctr | Downey | California | 902422814 | — |
| 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 Cedars-Sinai Medical Center | 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 | — |
| Children's Hosp of Oakland | Oakland | California | 946091809 | — |
| Univ of California / San Diego Treatment Ctr | San Diego | California | 921036325 | — |
| Northern California Pediatric AIDS Treatment Ctr / UCSF | San Francisco | California | 94143 | — |
| Olive View Med Ctr | Sylmar | California | 91342 | — |
| Univ of Connecticut Health Ctr / Pediatrics | Farmington | Connecticut | 06032 | — |
| Emory Univ School of Medicine | Atlanta | Georgia | 30303 | — |
| Cook County Hosp | Chicago | Illinois | 60612 | — |
| Univ of Illinois College of Medicine | Chicago | Illinois | 60612 | — |
| Chicago Children's Memorial Hosp | Chicago | Illinois | 606143394 | — |
| Tulane Univ School of Medicine | New Orleans | Louisiana | 70112 | — |
| 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 | — |
| Univ of Massachusetts Med Ctr | Worcester | Massachusetts | 01655 | — |
| Univ of Minnesota | Minneapolis | Minnesota | 55455 | — |
| Children's Hosp of New Jersey / UMDNJ - New Jersey Med Schl | Newark | New Jersey | 071072198 | — |
| SUNY / Health Sciences Ctr at Brooklyn / Pediatrics | Brooklyn | New York | 11203 | — |
| City Hosp Ctr at Elmhurst / Mount Sinai Hosp | Elmhurst | New York | 11373 | — |
| Schneider Children's Hosp / Long Island Jewish Med Ctr | New Hyde Park | New York | 11042 | — |
| 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 | — |
| Univ of Rochester Medical Center | Rochester | New York | 14642 | — |
| 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 | — |
| Duke Univ Med Ctr | Durham | North Carolina | 277103499 | — |
| 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 | — |
| Saint Christopher's Hosp for Children | Philadelphia | Pennsylvania | 191341095 | — |
| Julio Arroyo | West Columbia | South Carolina | 29169 | — |
| Hermann Hosp / Univ Texas Health Science Ctr | Houston | Texas | 77030 | — |
| Texas Children's Hosp / Baylor Univ | Houston | Texas | 77030 | — |
| Children's Hosp of Seattle | Seattle | Washington | 98105 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 3 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00000720, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Nov 3, 2021 · Synced Oct 30, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00000720 live on ClinicalTrials.gov.