Clinical trial NCT00002385: The Safety and Effectiveness of Fozivudine Tidoxil in HIV-1 Infected Patients
Official title: 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).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infections
Keywords: Dose-Response Relationship, Drug
Cohort Studies
Anti-HIV Agents
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
Collaborators: name: Boehringer Mannheim
First posted: 2001-08-31
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: