A Randomized Comparative Trial of Zidovudine (AZT) Versus 2',3'-Dideoxyinosine (ddI) Versus AZT Plus ddI in Symptomatic HIV-Infected Children
Public ClinicalTrials.gov record NCT00000637. 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 compare the effectiveness of treatment with zidovudine (AZT) compared to didanosine (ddI) and compared to the combination of AZT and ddI as determined by survival and disease progression. To compare the relative safety and tolerance of AZT versus ddI versus AZT plus ddI in symptomatic HIV infected children; to compare the virological and immunological parameters in the three treatment groups. AZT has been shown to delay the progression of AIDS in HIV infected individuals. However, bone marrow toxicity is a frequent adverse effect. Also, HIV resistance to AZT sometimes occurs in patients who initially respond to treatment, but later have progression of the disease. Thus, new drug treatments are needed. Studies of ddI in adults and children indicate some effectiveness of the drug. A direct comparison of AZT and ddI treatment in children has not been made. Combination antiviral treatment (AZT plus ddI) may give added therapeutic benefit to children.
Study identification
- NCT ID
- NCT00000637
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 819 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 3 Months to 17 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
- Sep 1996 (Actual)
- Last update posted
- Nov 2, 2021
Ends 1996
United States locations
- U.S. sites
- 76
- U.S. states
- 22
- U.S. cities
- 49
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Univ of Alabama at Birmingham Schl of Med / Pediatrics | Birmingham | Alabama | 35294 | — |
| Kaiser Permanente / UCLA Med Ctr | Downey | California | 902422814 | — |
| UCSD Med Ctr / Pediatrics / Clinical Sciences | La Jolla | California | 920930672 | — |
| Long Beach Memorial (Pediatric) | Long Beach | California | 90801 | — |
| 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 | — |
| Harbor - UCLA Med Ctr / UCLA School of Medicine | Los Angeles | California | 905022004 | — |
| Children's Hosp of Oakland | Oakland | California | 946091809 | — |
| Huntington Memorial Hosp / Children's Hosp of Los Angeles | Pasadena | California | 91105 | — |
| Univ of California / San Diego Treatment Ctr | San Diego | California | 921036325 | — |
| UCSF / Moffitt Hosp - Pediatric | San Francisco | California | 941430105 | — |
| Stanford Univ School of Medicine / Pediatrics | Stanford | California | 943054149 | — |
| Children's Hosp of Denver | Denver | Colorado | 802181088 | — |
| Univ of Connecticut Health Ctr | Farmington | Connecticut | 06032 | — |
| Yale Univ Med School | New Haven | Connecticut | 06504 | — |
| Georgetown Univ Med Ctr | Washington D.C. | District of Columbia | 200072197 | — |
| Children's Hosp of Washington DC | Washington D.C. | District of Columbia | 200102916 | — |
| Howard Univ Hosp | Washington D.C. | District of Columbia | 20060 | — |
| Univ of Miami (Pediatric) | Miami | Florida | 33161 | — |
| Emory Univ Hosp / Pediatrics | Atlanta | Georgia | 30306 | — |
| Cook County Hosp | Chicago | Illinois | 60612 | — |
| Univ of Illinois College of Medicine / Pediatrics | Chicago | Illinois | 60612 | — |
| Chicago Children's Memorial Hosp | Chicago | Illinois | 606143394 | — |
| Univ of Chicago Children's Hosp | Chicago | Illinois | 606371470 | — |
| 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 City Hosp / Pediatrics | Boston | Massachusetts | 02118 | — |
| Baystate Med Ctr of Springfield | Springfield | Massachusetts | 01199 | — |
| Univ of Massachusetts Med Ctr | Worcester | Massachusetts | 01655 | — |
| Children's Hosp of Michigan | Detroit | Michigan | 48201 | — |
| St Louis Univ School of Medicine | St Louis | Missouri | 63104 | — |
| UMDNJ - Robert Wood Johnson Med School / Pediatrics | New Brunswick | New Jersey | 089030019 | — |
| Robert Wood Johnson Med School / Hershey Med Ctr | New Brunswick | New Jersey | 08903 | — |
| Saint Joseph's Hosp and Med Ctr/UMDNJ - New Jersey Med Schl | Newark | New Jersey | 07103 | — |
| Children's Hosp of New Jersey / UMDNJ - New Jersey Med Schl | Newark | New Jersey | 071072198 | — |
| Children's Hosp at Albany Med Ctr | Albany | New York | 12208 | — |
| King's County Hosp Ctr / Pediatrics | Brooklyn | New York | 11203 | — |
| SUNY - Brooklyn | Brooklyn | New York | 11203 | — |
| SUNY / Health Sciences Ctr at Brooklyn / Pediatrics | Brooklyn | New York | 11203 | — |
| Children's Hosp Pact Prog / Children's Hosp of Buffalo | Buffalo | New York | 14222 | — |
| North Shore Univ Hosp | Great Neck | New York | 11021 | — |
| Schneider Children's Hosp | New Hyde Park | New York | 11040 | — |
| 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 / Pediatrics | New York | New York | 10029 | — |
| Columbia Presbyterian Med Ctr | New York | New York | 10032 | — |
| Incarnation Children's Ctr / Columbia Presbyterian Med Ctr | New York | New York | 10032 | — |
| Harlem Hosp Ctr | New York | New York | 10037 | — |
| Univ of Rochester Medical Center | Rochester | New York | 14642 | — |
| State Univ of New York at Stony Brook | Stony Brook | New York | 117948111 | — |
| SUNY Health Sciences Ctr at Syracuse / Pediatrics | Syracuse | New York | 13210 | — |
| Lincoln Hosp Ctr | The Bronx | New York | 10451 | — |
| Bronx Lebanon Hosp Ctr / Pediatrics | The Bronx | New York | 10457 | — |
| Bronx Lebanon Hosp Ctr | The Bronx | New York | 10457 | — |
| Albert Einstein College of Medicine | The Bronx | New York | 10461 | — |
| Westchester Hosp | Valhalla | New York | 10595 | — |
| Univ of North Carolina | Chapel Hill | North Carolina | 275997215 | — |
| Duke Univ Med Ctr | Durham | North Carolina | 277103499 | — |
| Cincinnati Children's Hosp / Univ Hosp | Cincinnati | Ohio | 452292899 | — |
| Case Western Reserve Univ | Cleveland | Ohio | 44106 | — |
| Columbus Children's Hosp | Columbus | Ohio | 432052696 | — |
| Children's Hosp of Philadelphia | Philadelphia | Pennsylvania | 191044318 | — |
| Saint Christopher's Hosp for Children | Philadelphia | Pennsylvania | 191341095 | — |
| Hemophilia Ctr of Western PA / Univ of Pittsburgh | Pittsburgh | Pennsylvania | 15219 | — |
| Rhode Island Hosp / Brown Univ | Providence | Rhode Island | 02903 | — |
| Med Univ of South Carolina | Charleston | South Carolina | 29425 | — |
| Saint Jude Children's Research Hosp of Memphis | Memphis | Tennessee | 381052794 | — |
| Children's Med Ctr of Dallas | Dallas | Texas | 75235 | — |
| 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 4 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00000637, 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 2, 2021 · Synced Oct 18, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00000637 live on ClinicalTrials.gov.