A Study of Dideoxycytidine Plus Zidovudine (AZT) in HIV-Infected Children Who Have Taken AZT
Public ClinicalTrials.gov record NCT00001032. 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 Phase II Study to Evaluate Pharmacokinetics, Safety, Tolerance and Activity of Dideoxycytidine (ddC) Administered in Combination With Zidovudine (AZT) in Stable, AZT-Treated Pediatric Patients With HIV Infection
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
PRIMARY: To determine safety, tolerance, and pharmacokinetics of zidovudine (AZT) and zalcitabine (dideoxycytidine; ddC) when given in combination in clinically stable AZT-treated children. SECONDARY: To compare combination therapy with mono drug therapy for antiviral activity and laboratory markers of disease progression, as determined by virologic and immunologic determinations. To evaluate the influence of combination therapy on disease progression as determined by evaluation of clinical criteria. In children currently being treated with AZT, it is unknown whether the addition of another antiretroviral agent such as ddC would help increase efficacy and tolerance. This study will examine the possible advantages of combination AZT/ddC therapy over monotherapy with AZT alone.
Study identification
- NCT ID
- NCT00001032
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 180 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 1995 (Actual)
- Last update posted
- Nov 4, 2021
Ends 1995
United States locations
- U.S. sites
- 44
- U.S. states
- 16
- U.S. cities
- 32
| 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 | — |
| San Francisco Gen. Hosp. | San Francisco | California | 94110 | — |
| UCSF Pediatric AIDS CRS | San Francisco | California | 94143 | — |
| Harbor - UCLA Med. Ctr. - Dept. of Peds., Div. of Infectious Diseases | Torrance | California | 90502 | — |
| 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/LSU Maternal/Child CRS | New Orleans | Louisiana | 70112 | — |
| Univ. of Maryland Med. Ctr., Div. of Ped. Immunology & Rheumatology | Baltimore | Maryland | 21201 | — |
| 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 | — | — |
| Univ. of Rochester ACTG CRS | Rochester | New York | 14642 | — |
| 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 | — |
| 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 | — |
| 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 NCT00001032, 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 Oct 28, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00001032 live on ClinicalTrials.gov.