Combination Drug Treatment of Pediatric HIV Infection
Public ClinicalTrials.gov record NCT00001818. 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 Pilot Study of Hydroxyurea in Combination With Stavudine, Didanosine and Efavirenz in Pediatric Patients With HIV-1 Infection
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This study will test the safety and effectiveness of hydroxyurea, an anti-cancer drug, given together with the anti-HIV drugs didanosine, stavudine and efavirenz for treating children infected with human immunodeficiency virus (HIV). Some studies have found that hydroxyurea may help certain anti-HIV drugs to work better and that the virus does not become resistant to it, as it does other drugs. This study will also examine how hydroxyurea affects the body's immune system and virus levels. Patients 3 through 21 years old with HIV infection may be eligible for this 52-week study. They will be screened for eligibility with a thorough physical examination, including chest X-ray, electrocardiogram and echocardiogram, head CT scan, eye examination and blood tests. All patients in the study will take didanosine twice a day, stavudine twice a day and efavirenz once a day. All patients will also take hydroxyurea twice a day, but some will take a low dose of the drug, while others will take a high dose. Within each of these two groups (high and low dose) some patients will start taking hydroxyurea the same day they begin the anti-HIV drugs; others will not start hydroxyurea until after they have taken the anti-HIV drugs for 5 weeks. Patients will have a physical examination every 3 weeks until week 12, then every 4 weeks until week 24, and then every 8 weeks until the end of the study. Blood tests to measure virus levels will be done every other day for the first 7 days and periodically after that. For the first 8 weeks after starting hydroxyurea, blood tests will be done weekly. An eye examination, chest X-ray, electrocardiogram, and CT scans of the head will be done about every 6 months.
Study identification
- NCT ID
- NCT00001818
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 50 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- Not listed
- 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
- May 31, 1999
- Primary completion
- Not listed
- Completion
- Oct 31, 2001
- Last update posted
- Mar 3, 2008
1999 – 2001
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| National Cancer Institute (NCI) | Bethesda | Maryland | 20892 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00001818, 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 Mar 3, 2008 · Synced Sep 1, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00001818 live on ClinicalTrials.gov.