Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

The Safety and Effectiveness of Fozivudine Tidoxil in HIV-1 Infected Patients

This study has been completed.
Sponsor:
Collaborator:
Boehringer Mannheim
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002385
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: April 1999

November 2, 1999
June 23, 2005
Not Provided
Not Provided
Not Provided
Not Provided
Complete list of historical versions of study NCT00002385 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
The Safety and Effectiveness of Fozivudine Tidoxil in HIV-1 Infected Patients
Multicenter, Rising, Multiple-Dose, Placebo-Controlled, Dose-Response Study to Evaluate the Safety, Tolerability, and Anti-Viral Activity of 4 Weeks of Treatment With 200-800 Mg Fozivudine Tidoxil in Patients With HIV-1 Infection (MF4314).

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.

In this double-blind, dose-escalating study, patients receive fozivudine tidoxil at one of 5 dosage levels for 4 weeks and are randomized with respect to once- or twice-daily administration (cohorts 2 vs. 3 and 4 vs. 5). Within each cohort, 10 patients are randomized to the study drug and 2 to the placebo. At least 9 of the 12 patients enrolled in Cohort 1 must complete the entire 4-week course before Cohorts 2 and 3 are enrolled. At least 18 of these 24 patients must complete 2 weeks of the 4-week course before Cohorts 4 and 5 are enrolled.

Interventional
Not Provided
Endpoint Classification: Pharmacokinetics Study
Masking: Double-Blind
Primary Purpose: Treatment
HIV Infections
Drug: Fozivudine tidoxil
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
Not Provided
Not Provided

Inclusion Criteria

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.

Exclusion Criteria

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:

Excluded:

  • Extended-field radiation therapy within 3 months prior to study drug administration.
  • Blood transfusion within 2 weeks prior to study drug administration.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00002385
277A, MF4314, 96ACR-BRM1
Not Provided
Not Provided
Anderson Clinical Research
Boehringer Mannheim
Not Provided
NIH AIDS Clinical Trials Information Service
April 1999

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP