The Safety of Different Dose Levels of Zidovudine in HIV-Infected Children
Public ClinicalTrials.gov record NCT00000983. 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.
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Official title
A Randomized Blinded Trial To Evaluate the Safety and Tolerance of High Versus Low Dose Zidovudine Administered to Children With Human Immunodeficiency Virus
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
To evaluate and compare differences in tolerance and side effects associated with two different dosages of zidovudine (AZT) when used to treat children with HIV infection. Other goals are to evaluate and compare the degree of change in neurodevelopmental disease and determine whether there are differences in the rate and degree of toxicities associated with one versus the other dosage. AZT has been shown to decrease the death rate and frequency of opportunistic infections in certain adult patients with symptomatic HIV infection. Thus, it is likely that symptomatic HIV infected children may also benefit from AZT. Studies of the safety and pharmacokinetics (blood levels) in children have indicated that AZT can be given to children in doses that can be tolerated and that can be assumed to be therapeutic. Those currently taking care of infected children no longer feel it is ethical to conduct an AZT/placebo (inactive substance) trial. In addition, given the information learned from studies of adult patients that shows effectiveness of AZT at lower doses, experience with an equivalent lower dose in children needs to be studied.
Study identification
- NCT ID
- NCT00000983
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 400 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
- Dec 1994 (Actual)
- Last update posted
- Nov 4, 2021
Ends 1994
United States locations
- U.S. sites
- 48
- U.S. states
- 15
- U.S. cities
- 31
| 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 | — |
| UCLA Med Ctr / Pediatric | Los Angeles | California | 900951752 | — |
| 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 | — |
| Univ of Connecticut Health Ctr / Pediatrics | Farmington | Connecticut | 06032 | — |
| Children's Natl Med Ctr | Washington D.C. | District of Columbia | 20010 | — |
| Ctr for Special Immunology | Fort Lauderdale | Florida | 33308 | — |
| Univ of Miami School of Medicine | Miami | Florida | 33136 | — |
| 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 | — |
| Univ of Maryland at Baltimore / Univ Med Ctr | Baltimore | Maryland | 21201 | — |
| Johns Hopkins Hosp - Pediatric | Baltimore | Maryland | 212874933 | — |
| Children's Hosp of Boston | Boston | Massachusetts | 021155724 | — |
| Boston Med Ctr | Boston | Massachusetts | 02118 | — |
| Univ of Massachusetts Med Ctr | Worcester | Massachusetts | 01655 | — |
| 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 | — |
| Jewish Hosp Ctr of Long Island / Pediatrics | Jamaica | New York | 11432 | — |
| 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 | — |
| Cornell Univ Med College | New York | New York | 10021 | — |
| 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 | — |
| Bronx Lebanon Hosp Ctr | The Bronx | New York | 10456 | — |
| Albert Einstein College of Medicine | The Bronx | New York | 10461 | — |
| Westchester Hosp / New York Med College / Pediatrics | Valhalla | New York | 10595 | — |
| Univ of North Carolina | Chapel Hill | North Carolina | 275997215 | — |
| Duke Univ Med Ctr | Durham | North Carolina | 277103499 | — |
| Bowman Gray School of Medicine / North Carolina Baptist Hosp | Winston-Salem | North Carolina | 27103 | — |
| Holmes Hosp / Univ of Cincinnati Med Ctr | Cincinnati | Ohio | 452670405 | — |
| Columbus Children's Hosp | Columbus | Ohio | 432052696 | — |
| Hemophilia Ctr of Western PA / Univ of Pittsburgh | Pittsburgh | Pennsylvania | 15219 | — |
| 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 | — |
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 NCT00000983, 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 4, 2021 · Synced Nov 6, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00000983 live on ClinicalTrials.gov.