A Trial of Two Doses of 2',3'-Dideoxycytidine (ddC) in the Treatment of Children With Symptomatic HIV Infection Who Are Intolerant of AZT and/or Who Show Progressive Disease While on AZT
Public ClinicalTrials.gov record NCT00000653. 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 and compare the long-term (48-177 weeks) safety, tolerance, and efficacy of two doses of zalcitabine ( dideoxycytidine; ddC ) taken orally every 8 hours in children with symptomatic HIV infection who have one of the following: intolerance to zidovudine ( AZT ) (development of toxicity during prolonged AZT therapy), demonstrated disease progression after 6 months of AZT therapy, OR both AZT intolerance and disease progression after 6 months of AZT therapy. As useful as AZT appears to be in the treatment of patients infected with HIV, it is associated with significant toxicity in some patients, and it does not prevent ultimate progression to AIDS and eventual mortality. Thus, there is a clear need for new antiretroviral drugs, and ddC is one such promising agent.
Study identification
- NCT ID
- NCT00000653
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 140 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
- Jun 1995 (Actual)
- Last update posted
- Oct 27, 2021
Ends 1995
United States locations
- U.S. sites
- 32
- U.S. states
- 13
- U.S. cities
- 24
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| UCLA-Los Angeles/Brazil AIDS Consortium (LABAC) CRS | Los Angeles | California | 90095 | — |
| 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 | — |
| Children's National Med. Ctr., ACTU | Washington D.C. | District of Columbia | 20010 | — |
| 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 | 30303 | — |
| 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 | — |
| 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 | — |
| UMDNJ - Robert Wood Johnson | New Brunswick | New Jersey | — | — |
| 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 | — | — |
| Schneider Children's Hosp., Div. of Infectious Diseases | New Hyde Park | New York | 11042 | — |
| 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 | — |
| Harlem Hosp. Ctr. NY NICHD CRS | New York | New York | 10037 | — |
| Univ. of Rochester ACTG CRS | Rochester | New York | 14642 | — |
| Bronx-Lebanon Hosp. IMPAACT CRS | The Bronx | New York | 10456 | — |
| UNC at Chapel Hill School of Medicine - Dept. of Peds., Div. of Immunology & Infectious Diseases | Chapel Hill | North Carolina | 27599 | — |
| DUMC Ped. CRS | Durham | North Carolina | 27710 | — |
| St. Christopher's Hosp. for Children | Philadelphia | Pennsylvania | 19134 | — |
| Texas Children's Hosp. CRS | 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 NCT00000653, 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 27, 2021 · Synced Oct 26, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00000653 live on ClinicalTrials.gov.