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

NCT ID: NCT00002385

Last Updated: 2005-06-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL

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.

Detailed Description

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.

Conditions

HIV Infections

Study Design

• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

Fozivudine tidoxil

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boehringer Mannheim

INDUSTRY

Sponsor Role: collaborator

Anderson Clinical Research

INDUSTRY

Sponsor Role: lead

Other Identifiers

MF4314

Identifier Type: -

Identifier Source: secondary_id

96ACR-BRM1

Identifier Type: -

Identifier Source: secondary_id

277A

Identifier Type: -

Identifier Source: org_study_id