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NCT00001443 · ClinicalTrials.gov registry record · Phase 1
A Phase I /II Study of the Protease Inhibitor Indinavir (MK-0639) in Children With HIV Infection
A Phase 1 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 1
- Development phase
- 63
- Enrollment target
NCT00001443: Completed Phase 1 study, sponsored by National Cancer Institute (NCI).
NCT00001443 is a Phase 1 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 63 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00001443, a Phase 1 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 63 participants
- Enrollment target
Study Summary
This is a phase I/II study to determine the safety and tolerance of the protease inhibitor indinavir (MK-0639), alone and then in combination with HIV reverse transcriptase inhibitor therapy in children with HIV infection. Indinavir sulfate (the capsule formulation) has been shown to have potent antiviral activity and an acceptable safety profile in adults. HIV-infected children who have not received prior antiretroviral therapy, and children who have become refractory to prior therapy, or who have experienced toxicity to prior therapy, will be included. In addition, we will explore viral and CD4 cell kinetics before starting therapy and following exposure to antiretroviral agents. The study will be conducted in three parts. 1. In order to help interpret the antiviral activity of indinavir, the virologic and immunologic profile of children will be studied within 2 weeks prior to starting the therapeutic part. For children who have never been treated, this will be before the initiation of any antiretroviral therapy and for children who have already received antiretroviral therapy, this will be done during the initial "wash-out" phase that is routinely interposed between two different treatment regimens. 2. The initial 16 weeks of therapy will then evaluate the toxicities, pharmacokinetics, and preliminary efficacy of single drug therapy with indinavir. 3. Subsequently, all children who are able to tolerate the combination of zidovudine and lamivudine (i.e., have no prior history of intolerance to one of these two agents) will be treated with these two reverse transcriptase inhibitors in addition to the protease inhibitor indinavir. Zidovudine and lamivudine will be added after 16 weeks at a fixed dosage. Toxicity, pharmacokinetics, and preliminary efficacy of indinavir will also be investigated after combination therapy. All patients who wish to remain in this study after 96 weeks of therapy and who do not meet off study criteria will be permitted to receive extend
Interventions
- DRUG indinavir (MK-0639)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 63 participants |
| Start Date | 1995-07 |
| Est. Completion | 2000-10 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00001443
The ClinicalTrials.gov registry entry for NCT00001443 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 63 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which indinavir (MK-0639) is the first listed.
NCT00001443 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00001443 about?
NCT00001443 is a clinical study titled "A Phase I /II Study of the Protease Inhibitor Indinavir (MK-0639) in Children With HIV Infection". This is a phase I/II study to determine the safety and tolerance of the protease inhibitor indinavir (MK-0639), alone and then in combination with HIV reverse transcriptase inhibitor therapy in children with HIV infection. Indinavir sulfate (the capsule formulation) has been shown to have potent ant...
What is the current status of trial NCT00001443?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 63 participants. The study started on 1995-07. Estimated completion is 2000-10.
What interventions are being tested in trial NCT00001443?
The interventions under investigation include: indinavir (MK-0639) (DRUG).
Who is sponsoring clinical trial NCT00001443?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
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