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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: Completed Phase 1 study of HIV Infections and Cytomegalovirus Infections, sponsored by Hoffmann-La Roche.

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. According to ClinicalTrials.gov, the official US trial registry.

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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

HIV Infections Cytomegalovirus Infections

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

FieldValue
Enrollment Target 24 participants
Phase Phase 1
Hoffmann-La Roche

909 total trials

What the finished NCT00002096 record still lists

NCT00002096 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (95% lower).

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 a single indexed study location in 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.

Learn More About Clinical Trials

Similar trials for HIV Infections

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT00002096's enrollment target sits among peer trials

24 470th of 542 higher than 64 of 542 other HIV Infections trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other HIV Infections 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.

Source ClinicalTrials.gov registry export · 2026-08-08

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Related registry views

Source: ClinicalTrials.gov NCT00002096, the US trial registry maintained by the National Library of Medicine. NCT00002096 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.