Comparison of Stavudine Used Alone or in Combination With Didanosine in HIV-Infected Children
Public ClinicalTrials.gov record NCT00000851. 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
Trial of Stavudine (d4T) Plus Didanosine (ddI) in Children on Long-Term Stavudine Monotherapy, and Stavudine Versus Stavudine Plus Didanosine in Children on Long-Term Zidovudine Monotherapy: A Rollover Protocol for ACTG 240 Participants and Children Receiving Prescription Zidovudine
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
To evaluate the safety and determine the pharmacokinetic disposition of stavudine (d4T) alone and in combination with didanosine (ddI), and whether concurrent administration alters the disposition of either drug. To compare d4T versus d4T plus ddI with respect to short and long term changes from baseline in plasma HIV RNA concentrations. To determine the relationship, if any, between drug exposure and viral burden. In a pilot study of d4T and ddI given to eight children with advanced HIV for 24 weeks, the three children with baseline counts greater than 50 cells/micro liter experienced a 20% increase in their CD4+ lymphocyte counts. Based on these results, controlled trials of the same regimen for children with less advanced HIV disease should be undertaken.
Study identification
- NCT ID
- NCT00000851
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 198 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 6 Months to 10 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
- Oct 1998 (Actual)
- Last update posted
- Nov 4, 2021
Ends 1998
United States locations
- U.S. sites
- 32
- U.S. states
- 16
- U.S. cities
- 26
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Harbor - UCLA Med. Ctr. - Dept. of Peds., Div. of Infectious Diseases | Torrance | California | 90502 | — |
| Univ. of Colorado Denver NICHD CRS | Aurora | Colorado | — | — |
| Univ. of Connecticut Health Ctr., Dept. of Ped. | Farmington | Connecticut | 06032 | — |
| Connecticut Children's Med. Ctr. | Hartford | Connecticut | — | — |
| 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 Florida Jacksonville NICHD CRS | Jacksonville | Florida | 32209 | — |
| Univ. of Miami Ped. Perinatal HIV/AIDS CRS | Miami | Florida | 33161 | — |
| Cook County Hosp. | 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 | — |
| Children's Hospital of Michigan NICHD CRS | Detroit | Michigan | 48201 | — |
| UMDNJ - Robert Wood Johnson | New Brunswick | New Jersey | 08903 | — |
| NJ Med. School CRS | Newark | 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 | 11021 | — |
| Schneider Children's Hosp., Div. of Infectious Diseases | New Hyde Park | New York | 11040 | — |
| 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 | — |
| Strong Memorial Hospital Rochester NY NICHD CRS | Rochester | New York | — | — |
| SUNY Stony Brook NICHD CRS | Stony Brook | New York | — | — |
| Bronx-Lebanon Hosp. IMPAACT CRS | The Bronx | New York | 10457 | — |
| DUMC Ped. CRS | Durham | North Carolina | 27710 | — |
| 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 | — |
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 NCT00000851, 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 9, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00000851 live on ClinicalTrials.gov.