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NCT00002096 · ClinicalTrials.gov registry record · Phase 1
A Phase I Pharmacokinetic Study in HIV-Positive Subjects of Oral Ganciclovir and Concomitant Antiretroviral Zidovudine and Didanosine
A Phase 1 study of HIV Infections and Cytomegalovirus Infections, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
- 3
- Study locations
NCT00002096 is a Phase 1 study of HIV Infections and Cytomegalovirus Infections that has completed, run by Hoffmann-La Roche. The registered enrollment target is 24 participants, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (95% lower). The trial reports 3 study locations across 3 states.
The verdict
NCT00002096, a Phase 1 study of HIV Infections and Cytomegalovirus Infections, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
- 3
- Study locations
Study Summary
To determine whether there is a pharmacokinetic drug interaction between oral ganciclovir and oral zidovudine (AZT) and between oral ganciclovir and oral didanosine (ddI). To determine whether concurrent administration of probenecid affects the pharmacokinetics of oral ganciclovir. To obtain data on the short-term safety of oral ganciclovir administered concurrently with AZT, ddI, or probenecid in HIV-positive patients.
Conditions Studied
Interventions
- DRUG Zidovudine
- DRUG Didanosine
- DRUG Ganciclovir
Study Locations (3)
California
- Ctr for Special Immunology - Irvine
District of Columbia
- Georgetown Univ Med Ctr - Washington D.C.
Texas
- Univ TX Galveston Med Branch - Galveston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00002096
The ClinicalTrials.gov registry entry for NCT00002096 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (95% lower). The listed sponsor is Hoffmann-La Roche, which has 909 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with HIV Infections appearing as the primary indexed condition, and to 3 interventions - of which Zidovudine is the first listed.
NCT00002096 reports 3 study locations spanning 3 distinct geographic areas - top geographies include California, District of Columbia, Texas.
Frequently Asked Questions
What is clinical trial NCT00002096 about?
NCT00002096 is a clinical study titled "A Phase I Pharmacokinetic Study in HIV-Positive Subjects of Oral Ganciclovir and Concomitant Antiretroviral Zidovudine and Didanosine". To determine whether there is a pharmacokinetic drug interaction between oral ganciclovir and oral zidovudine (AZT) and between oral ganciclovir and oral didanosine (ddI). To determine whether concurrent administration of probenecid affects the pharmacokinetics of oral ganciclovir. To obtain data on...
What is the current status of trial NCT00002096?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants.
What conditions does trial NCT00002096 study?
This clinical trial studies the following conditions: HIV Infections, Cytomegalovirus Infections.
What interventions are being tested in trial NCT00002096?
The interventions under investigation include: Zidovudine (DRUG), Didanosine (DRUG), Ganciclovir (DRUG).
Who is sponsoring clinical trial NCT00002096?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00002096 being conducted?
This trial has 3 study locations across California, District of Columbia, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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