HIV InfectionsNCT00002385
The Safety and Effectiveness of Fozivudine Tidoxil in HIV-1 Infected Patients
A study testing Fozivudine tidoxil in people with HIV Infections, run by Anderson Clinical Research.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections
- What is being tested?
- Fozivudine tidoxil
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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:
Show all 18Show fewer
- 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.
About this 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).
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.
Read the 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
- Being tested
- Fozivudine tidoxil
- Keywords
- Dose-Response Relationship, Drug, Cohort Studies, Anti-HIV Agents
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fozivudine tidoxilDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2001 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Masking
- Double blind
- Enrolment
- 60 participants
Sponsor and investigators
- Lead sponsor
- Anderson Clinical Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Boehringer Mannheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002385
- Sponsor's protocol ID
- 277A
- Other IDs
- MF4314, 96ACR-BRM1
- Status last verified
- Apr 1999
- First submitted
- 2 Nov 1999
- Last updated
- 24 Jun 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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).
- ClinicalTrials.gov ID
- NCT00002385
- Acronym / sponsor ID
- 277A
- Conditions
- HIV Infections
- Keywords
- Dose-Response Relationship, Drug, Cohort Studies, Anti-HIV Agents
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants
- Lead sponsor
- Anderson Clinical ResearchIndustry (pharma, biotech, devices)
- Collaborators
- Boehringer Mannheim
- First posted
- 31 Aug 2001 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Primary and secondary prophylaxis for opportunistic infection if stable and initiated at least 3 months prior to study drug administration.
- 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.
Key exclusion criteria (18 listed)
- 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.
- Systemic therapy for malignancy.
- Zidovudine or any other nucleoside reverse transcriptase inhibitor.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fozivudine tidoxil | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2005.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Fozivudine tidoxil in people with HIV Infections, run by Anderson Clinical Research.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2005. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2005.