A Study of Dideoxyinosine (ddI) in HIV-Infected Children Who Have Not Had Success With Zidovudine or Who Cannot Take Zidovudine
Public ClinicalTrials.gov record NCT00000963. 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.
Official title
A Randomized Comparative Trial of Two Doses of 2',3'-Dideoxyinosine (ddI) in Children With Symptomatic HIV Infection Who Are Either Unresponsive to Zidovudine and/or Who Are Intolerant to Zidovudine
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
To evaluate the effectiveness, safety, and tolerance of two doses of didanosine (ddI) in the treatment of children with symptomatic HIV disease who have had to discontinue zidovudine (AZT) because of intolerance and/or who have experienced progressive disease while on AZT. The progression of immunodeficiency due to HIV infection can be delayed by using AZT. The benefits of AZT in adults with AIDS and severe AIDS-related complex (ARC) appear to last for approximately 12 to 18 months, at which time most patients have progressive deterioration. Recently published literature has described a reduced sensitivity of HIV isolated from patients after prolonged AZT treatment. Although the clinical significance of this is unclear, it makes the development of new antiretroviral drugs important.
Study identification
- NCT ID
- NCT00000963
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 300 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 3 Months to 18 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 1995 (Actual)
- Last update posted
- Oct 29, 2021
Ends 1995
United States locations
- U.S. sites
- 49
- U.S. states
- 18
- U.S. cities
- 36
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Long Beach Memorial Med. Ctr., Miller Children's Hosp. | Long Beach | California | 90801 | — |
| Usc La Nichd Crs | Los Angeles | California | 90033 | — |
| UCLA-Los Angeles/Brazil AIDS Consortium (LABAC) CRS | Los Angeles | California | — | — |
| Children's Hosp. & Research Ctr. Oakland, Ped. Clinical Research Ctr. & Research Lab. | Oakland | California | 94609 | — |
| UCSD Maternal, Child, and Adolescent HIV CRS | San Diego | California | 92093 | — |
| UCSF Pediatric AIDS CRS | San Francisco | California | 94143 | — |
| Harbor - UCLA Med. Ctr. - Dept. of Peds., Div. of Infectious Diseases | Torrance | California | — | — |
| Univ. of Connecticut Health Ctr., Dept. of Ped. | Farmington | Connecticut | 06032 | — |
| Yale Univ. School of Medicine - Dept. of Peds., Div. of Infectious Disease | New Haven | Connecticut | 06504 | — |
| Children's National Med. Ctr., ACTU | Washington D.C. | District of Columbia | 20010 | — |
| Howard Univ. Washington DC NICHD CRS | Washington D.C. | District of Columbia | 20060 | — |
| Univ. of Miami Ped. Perinatal HIV/AIDS CRS | Miami | Florida | 33161 | — |
| Emory Univ. School of Medicine, Dept. of Peds., Div. of Infectious Diseases | Atlanta | Georgia | 30306 | — |
| Cook County Hosp. | Chicago | Illinois | 60612 | — |
| Univ. of Illinois College of Medicine at Chicago, Dept. of Peds. | Chicago | Illinois | 60612 | — |
| Chicago Children's CRS | Chicago | Illinois | 60614 | — |
| Univ. of Chicago - Dept. of Peds., Div. of Infectious Disease | Chicago | Illinois | 60637 | — |
| Tulane Med. Ctr. - Charity Hosp. of New Orleans, ACTU | New Orleans | Louisiana | — | — |
| Tulane/LSU Maternal/Child CRS | New Orleans | Louisiana | — | — |
| Univ. of Maryland Med. Ctr., Div. of Ped. Immunology & Rheumatology | Baltimore | Maryland | 21201 | — |
| Johns Hopkins Hosp. & Health System - Dept. of Peds., Div. of Infectious Diseases | Baltimore | Maryland | 21287 | — |
| HMS - Children's Hosp. Boston, Div. of Infectious Diseases | Boston | Massachusetts | 02115 | — |
| BMC, Div. of Ped Infectious Diseases | Boston | Massachusetts | 02118 | — |
| Baystate Health, Baystate Med. Ctr. | Springfield | Massachusetts | 01199 | — |
| WNE Maternal Pediatric Adolescent AIDS CRS | Worcester | Massachusetts | 01655 | — |
| Children's Hospital of Michigan NICHD CRS | Detroit | Michigan | 48201 | — |
| UMDNJ - Robert Wood Johnson | New Brunswick | New Jersey | — | — |
| St. Joseph's Hosp. & Med. Ctr. of New Jersey | Paterson | New Jersey | — | — |
| Children's Hospital at Albany Medical Center, Dept. of Peds. | Albany | New York | 12208 | — |
| SUNY Downstate Med. Ctr., Children's Hosp. at Downstate NICHD CRS | Brooklyn | New York | 11203 | — |
| North Shore-Long Island Jewish Health System, Dept. of Peds. | Great Neck | New York | 11021 | — |
| Schneider Children's Hosp., Div. of Infectious Diseases | New Hyde Park | New York | 11040 | — |
| NYU Med. Ctr., Dept. of Medicine | New York | New York | 10016 | — |
| Metropolitan Hosp. NICHD CRS | New York | New York | 10029 | — |
| Columbia IMPAACT CRS | New York | New York | 10032 | — |
| Incarnation Children's Ctr. | New York | New York | 10032 | — |
| Harlem Hosp. Ctr. NY NICHD CRS | New York | New York | 10037 | — |
| Univ. of Rochester ACTG CRS | Rochester | New York | 14642 | — |
| SUNY Stony Brook NICHD CRS | Stony Brook | New York | 11794 | — |
| SUNY Upstate Med. Univ., Dept. of Peds. | Syracuse | New York | 13210 | — |
| Bronx-Lebanon Hosp. IMPAACT CRS | The Bronx | New York | 10457 | — |
| DUMC Ped. CRS | Durham | North Carolina | 27710 | — |
| Case CRS | Cleveland | Ohio | 44106 | — |
| The Children's Hosp. of Philadelphia IMPAACT CRS | Philadelphia | Pennsylvania | 19104 | — |
| St. Christopher's Hosp. for Children | Philadelphia | Pennsylvania | 19134 | — |
| Med. Univ. of South Carolina, Div. of Ped. Infectious Diseases | Charleston | South Carolina | 29425 | — |
| Children's Med. Ctr. Dallas | Dallas | Texas | 75235 | — |
| Texas Children's Hosp. CRS | Houston | Texas | 77030 | — |
| UW School of Medicine - CHRMC | 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 NCT00000963, 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 Oct 29, 2021 · Synced Oct 28, 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 NCT00000963 live on ClinicalTrials.gov.