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NCT00002321 · ClinicalTrials.gov registry record · Phase 1
A Phase I Study of the Safety of Proleukin (Aldesleukin) in Combination With Ganciclovir and Antiretroviral Therapy in HIV Seropositive Patients With Cytomegalovirus (CMV) Retinitis
A Phase 1 study, sponsored by Chiron Corporation.
- Completed
- Registry status
- Phase 1
- Development phase
NCT00002321 is a Phase 1 study that has completed, run by Chiron Corporation.
The verdict
NCT00002321, a Phase 1 study, has completed, sponsored by Chiron Corporation.
- COMPLETED
- Registry status
- Phase 1
- Development phase
Study Summary
To determine the MTD and dose-limiting toxicities of a regimen of therapeutic ganciclovir, antiretroviral therapy, and recombinant interleukin-2 (aldesleukin; Proleukin) as an immune adjuvant in HIV-seropositive patients. To investigate the effect of increasing doses of Proleukin on the time to progression of CMV retinitis in patients being treated with therapeutic ganciclovir and antiretroviral therapy. To evaluate the incidence and level of anti-IL-2 antibody formation to subcutaneously administered Proleukin in this patient population.
Interventions
- DRUG Aldesleukin
Trial Details
| Field | Value |
|---|---|
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00002321
The ClinicalTrials.gov registry entry for NCT00002321 describes a study currently listed as completed, categorized as Phase 1. An enrollment target was not published in the registry record, which is common for early-stage or observational entries. The listed sponsor is Chiron Corporation, which has 9 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Aldesleukin is the first listed.
NCT00002321 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00002321 about?
NCT00002321 is a clinical study titled "A Phase I Study of the Safety of Proleukin (Aldesleukin) in Combination With Ganciclovir and Antiretroviral Therapy in HIV Seropositive Patients With Cytomegalovirus (CMV) Retinitis". To determine the MTD and dose-limiting toxicities of a regimen of therapeutic ganciclovir, antiretroviral therapy, and recombinant interleukin-2 (aldesleukin; Proleukin) as an immune adjuvant in HIV-seropositive patients. To investigate the effect of increasing doses of Proleukin on the time to prog...
What is the current status of trial NCT00002321?
This trial is currently completed. It is a Phase 1 study.
What interventions are being tested in trial NCT00002321?
The interventions under investigation include: Aldesleukin (DRUG).
Who is sponsoring clinical trial NCT00002321?
This trial is sponsored by Chiron Corporation, which has 9 total clinical trials registered on ClinicalTrials.gov.
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