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Sponsors and Collaborators: |
Anderson Clinical Research Boehringer Mannheim |
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Information provided by: | NIH AIDS Clinical Trials Information Service |
ClinicalTrials.gov Identifier: | NCT00002385 |
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.
Condition | Intervention |
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HIV Infections |
Drug: Fozivudine tidoxil |
Study Type: | Interventional |
Study Design: | Treatment, Double-Blind, Pharmacokinetics Study |
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). |
Estimated Enrollment: | 60 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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:
Exclusion Criteria
Co-existing Condition:
Patients with the following conditions or symptoms are excluded:
Concurrent Medication:
Excluded:
Systemic therapy for malignancy.
Prior Medication:
Excluded:
Prior Treatment:
Excluded:
Study ID Numbers: | 277A, MF4314, 96ACR-BRM1 |
Study First Received: | November 2, 1999 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00002385 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Dose-Response Relationship, Drug Cohort Studies Anti-HIV Agents |
Virus Diseases Sexually Transmitted Diseases, Viral Anti-HIV Agents HIV Infections |
Sexually Transmitted Diseases Acquired Immunodeficiency Syndrome Retroviridae Infections Immunologic Deficiency Syndromes |
Communicable Diseases RNA Virus Infections Sexually Transmitted Diseases, Viral Slow Virus Diseases Immune System Diseases Acquired Immunodeficiency Syndrome Infection |
Immunologic Deficiency Syndromes Virus Diseases HIV Infections Sexually Transmitted Diseases Lentivirus Infections Retroviridae Infections |