A Phase I Study of Combination Therapy With Didanosine (ddI) and Ribavirin in HIV-Infected Children.
Public ClinicalTrials.gov record NCT00000833. 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 safety, toxicity, and tolerance of two doses of ribavirin in combination with didanosine (ddI) to HIV-infected children. To determine the toxicity of ddI/ribavirin and compare it to the expected toxicity of ddI monotherapy. To determine the effect of concurrent ribavirin on the pharmacokinetics of ddI. To determine a dosage of ribavirin that would be suitable for a Phase II/III evaluation of ddI/ribavirin. Ribavirin, a broad spectrum antiviral agent, may enhance the antiretroviral activity of didanosine ( ddI ) without a concomitant increase in toxicity. Ribavirin alters the intracellular metabolism of ddI, enhancing the antiretroviral activity of the active form of ddI.
Study identification
- NCT ID
- NCT00000833
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 20 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
- Jul 1998 (Actual)
- Last update posted
- Oct 28, 2021
Ends 1998
United States locations
- U.S. sites
- 14
- U.S. states
- 8
- U.S. cities
- 10
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| 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 Florida Health Science Ctr / Pediatrics | Jacksonville | Florida | 32209 | — |
| Tulane Univ / Charity Hosp of New Orleans | New Orleans | Louisiana | 701122699 | — |
| Children's Hosp of Boston | Boston | Massachusetts | 021155724 | — |
| Univ of Medicine & Dentistry of New Jersey / Univ Hosp | Newark | New Jersey | 071032714 | — |
| Children's Hosp of New Jersey / UMDNJ - New Jersey Med Schl | Newark | New Jersey | 071072198 | — |
| Schneider Children's Hosp | New Hyde Park | New York | 11040 | — |
| 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 | — |
| Bronx Lebanon Hosp Ctr | The Bronx | New York | 10457 | — |
| Glaxo Wellcome Inc | Research Triangle Park | North Carolina | 27709 | — |
| Texas Children's Hosp / Baylor Univ | 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 1 non-U.S. site.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00000833, 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 28, 2021 · Synced Nov 2, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00000833 live on ClinicalTrials.gov.