NCT00002385

Brief Summary

To identify doses of fozivudine tidoxil that are well tolerated and produce measurable antiviral activity. To identify the adverse event profile that defines the maximum tolerated dose. To characterize the single- and multiple-dose pharmacokinetics of fozivudine and its metabolites. To correlate the adverse event profile and antiviral activity of fozivudine with pharmacokinetic parameters.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable hiv-infections

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 2, 1999

Completed
1.8 years until next milestone

First Posted

Study publicly available on registry

August 31, 2001

Completed
Last Updated

June 24, 2005

Status Verified

April 1, 1999

First QC Date

November 2, 1999

Last Update Submit

June 23, 2005

Conditions

HIV Infections

Keywords

Dose-Response Relationship, DrugCohort StudiesAnti-HIV Agents

Interventions

Fozivudine tidoxilDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Concurrent Medication:
  • Allowed:
  • Primary and secondary prophylaxis for opportunistic infection if stable and initiated at least 3 months prior to study drug administration.
  • Patients must have:
  • HIV-positive status.
  • One HIV RNA count \> 10,000 copies/ml within 30 days prior to entry, with a second count at least 3-fold above or below the first value.

You may not qualify if:

  • Co-existing Condition:
  • Patients with the following conditions or symptoms are excluded:
  • Active medical problems including chronic diarrhea and active opportunistic infections such as cryptococcosis, Pneumocystis carinii, histoplasmosis, etc..
  • Malignancy for which systemic therapy or radiation therapy is expected to be required during the study.
  • Any other disease or condition that would place a patient at undue risk or confound the results of the study.
  • Concurrent Medication:
  • Excluded:
  • Systemic therapy for malignancy.
  • Prior Medication:
  • Excluded:
  • Zidovudine or any other nucleoside reverse transcriptase inhibitor.
  • Immunomodulators within one month prior to study drug administration.
  • Investigational drugs within 30 days prior to study drug administration.
  • Systemic cytotoxic chemotherapy within 3 months prior to study drug administration.
  • Prior Treatment:
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

HIV Infections

Interventions

fozivudine tidoxil

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Masking
DOUBLE
Purpose
TREATMENT
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 2, 1999

First Posted

August 31, 2001

Last Updated

June 24, 2005

Record last verified: 1999-04