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NCT00006519 · ClinicalTrials.gov registry record · Phase 1
Capravirine to Treat Children With HIV Infection
A Phase 1 study of HIV Infection, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 1
- Development phase
- 96
- Enrollment target
- 1
- Study location
NCT00006519: Completed Phase 1 study of HIV Infection, sponsored by National Cancer Institute (NCI).
NCT00006519 is a Phase 1 study of HIV Infection that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 96 participants, below the 241-participant average among 73 other HIV Infection trials with a reported enrollment target (60% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00006519, a Phase 1 study of HIV Infection, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 96 participants
- Enrollment target
- 1
- Study location
Study Summary
This study will test the safety, side effects and anti-HIV activity of different doses of capravirine in children and adolescents with HIV infection. Capravirine belongs to a class of drugs called non-nucleoside reverse transcriptase inhibitors (NNRTIs), which prevent the virus from replicating (making more copies of itself). Other NNRTIs are nevirapine, delavirdine and efavirenz. HIV-infected children between the ages of 4 months and 21 years may be eligible for this study if they: 1) have received less than 6 weeks of treatment with antiretroviral drugs; 2) have not benefited from antiretroviral therapy after 12 weeks of treatment; 3) cannot continue antiretroviral treatment because of harmful side effects. For the first week of the study, participants will have a 1-week "washout period" in which they will receive no anti-HIV therapy. During this time, they will have physical, eye and neuropsychologic examinations, blood and urine tests, echocardiogram, electrocardiogram (EKG), chest X-ray, head CT scan and skin tests. These physical exams and tests will be repeated throughout the study to determine changes in health. After the washout period, patients will take capravirine once a day in the morning for 6 days. After each dose, a small amount of blood will be drawn at 8 different times over 12 hours to measure the activity of the drug and HIV blood levels. A heparin lock will be placed in the vein to avoid multiple needlesticks. After the 6 days of capravirine there will be another washout period, this time for 21 days. During this time, doctors will determine the optimum combination therapy for the individual patient. After the second washout, patients will begin combination therapy with capravirine plus at least two other anti-HIV medicines. (These may include a reverse transcriptase inhibitor such as zidovudine, didanosine, lamuvidine, zalcitabine, or stavudine, and maybe one or more protease inhibitors such as ritonavir, nelfinavir, saquinavir, indinavir o
Conditions Studied
Interventions
- DRUG Capravirine
Study Locations (1)
Maryland
- National Cancer Institute (NCI) - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 96 participants |
| Start Date | 2000-11 |
| Est. Completion | 2004-10 |
| Phase | Phase 1 |
What the finished NCT00006519 record still lists
NCT00006519 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 96 participants, a relatively small participant target, below the 241-participant average among 73 other HIV Infection trials with a reported enrollment target (60% lower).
The record links to 1 condition, with HIV Infection appearing as the primary indexed condition, and to 1 intervention - of which Capravirine is the first listed.
NCT00006519 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT00006519 about?
NCT00006519 is a clinical study titled "Capravirine to Treat Children With HIV Infection". This study will test the safety, side effects and anti-HIV activity of different doses of capravirine in children and adolescents with HIV infection. Capravirine belongs to a class of drugs called non-nucleoside reverse transcriptase inhibitors (NNRTIs), which prevent the virus from replicating (mak...
What is the current status of trial NCT00006519?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 96 participants. The study started on 2000-11. Estimated completion is 2004-10.
What conditions does trial NCT00006519 study?
This clinical trial studies the following conditions: HIV Infection.
What interventions are being tested in trial NCT00006519?
The interventions under investigation include: Capravirine (DRUG).
Who is sponsoring clinical trial NCT00006519?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00006519 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00006519's enrollment target sits among peer trials
96 28th of 73 higher than 46 of 73 other HIV Infection trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other HIV Infection trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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