HIV InfectionsPhase 1NCT00002337
A Study of Multiple Doses of Vesnarinone in Advanced HIV Disease
A Phase 1 study testing Vesnarinone in people with HIV Infections, run by Otsuka America Pharmaceutical at 1 site in United States.
Trial summary
To evaluate the safety and tolerability of four doses of oral vesnarinone in patients with advanced HIV disease. 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?
- Vesnarinone
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- Start not givento not given
- Phase
- Phase 1
- 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:
- Chemoprophylaxis for Pneumocystis carinii, candida, mycobacteria, and other opportunistic infections.
- Acyclovir for up to 14 days for acute herpes outbreaks.
- Patients must have:
- Documented HIV infection.
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- CD4 count 50 - 300 cells/mm3.
- No active opportunistic infections.
- No fever, diarrhea, or Herpes zoster.
Who cannot join
- Co-existing Condition:
- Patients with the following symptoms or conditions are excluded:
- Clinically significant current cardiac disease, including patients who exhibit long QTC syndrome on EKG screening and who have an abnormal cardiothoracic ratio on chest x-ray at baseline.
- Active malignancy (other than cutaneous Kaposi's sarcoma or cutaneous basal cell carcinoma or in situ carcinoma of the cervix).
- Concurrent Medication:
- Excluded:
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- Antiretroviral agents, including ddI, ddC, AZT, and d4T.
- Immunosuppressive agents.
- Investigational HIV drugs/therapies including vaccines.
- Interferon or other immunomodulating agents.
- Corticosteroids (other than topical).
- Hematopoietins.
- Megestrol acetate.
- Agents known to cause neutropenia.
- Trimethoprim/sulfamethoxazole in excess of 160 mg trimethoprim and 800 mg sulfamethoxazole thrice weekly.
- Cytotoxic chemotherapy.
- Concurrent Treatment:
- Excluded:
- Radiation therapy.
- Patients with the following prior conditions are excluded:
- Prior history of cardiac disease.
- History of agranulocytosis or severe (grade 3 or worse) drug-induced neutropenia or documented abnormalities in granulocyte function.
- Prior Medication:
- Excluded:
- AZT, ddI, ddC, d4T, or other nucleoside analog antiretroviral therapy within 14 days prior to study entry.
- Prior cytotoxic chemotherapy.
- Acyclovir for herpes prophylaxis within 48 hours prior to study entry.
- Prior Treatment:
- Excluded within 30 days prior to study entry:
- Erythropoietin, transfusion, or blood product use.
- Radiation therapy (including electron beam irradiation). Active use of illicit drugs (specifically cocaine, amyl nitrate, heroin, and other cardioactive agents).
Trial locations and contacts
1 site in 1 country.
United States1 site
AIDS Research Consortium of Atlanta
Atlanta, Georgia, 30308
About this study
Official title: A Phase I Safety and Tolerability Study of Four Doses of OPC-8212 (Vesnarinone) in Advanced HIV Disease
To evaluate the safety and tolerability of four doses of oral vesnarinone in patients with advanced HIV disease.
Read the detailed description
Fourteen patients per dose level receive vesnarinone at 1 of 4 doses for 12 weeks. At least seven patients at a given dose level must have completed 4 weeks of treatment before dose is escalated in subsequent patients.
- Conditions
- HIV Infections
- Being tested
- Vesnarinone
- Keywords
- Acquired Immunodeficiency Syndrome, Antiviral Agents, vesnarinone
- Medical subject headings
- HIV Infections, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VesnarinoneDrug
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 1
- Primary purpose
- Treatment
- Masking
- None (open label)
- Enrolment
- 56 participants
Sponsor and investigators
- Lead sponsor
- Otsuka America Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002337
- Sponsor's protocol ID
- 234B
- Other IDs
- 22-93-252
- Status last verified
- Apr 1996
- 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
- A Phase I Safety and Tolerability Study of Four Doses of OPC-8212 (Vesnarinone) in Advanced HIV Disease
- ClinicalTrials.gov ID
- NCT00002337
- Acronym / sponsor ID
- 234B
- Conditions
- HIV Infections
- Keywords
- Acquired Immunodeficiency Syndrome, Antiviral Agents, vesnarinone
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants
- Lead sponsor
- Otsuka America PharmaceuticalIndustry (pharma, biotech, devices)
- 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 evaluate the safety and tolerability of four doses of oral vesnarinone in patients with advanced HIV disease.
Detailed description
Fourteen patients per dose level receive vesnarinone at 1 of 4 doses for 12 weeks. At least seven patients at a given dose level must have completed 4 weeks of treatment before dose is escalated in subsequent patients.
Study design
- Primary purpose
- Treatment
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Chemoprophylaxis for Pneumocystis carinii, candida, mycobacteria, and other opportunistic infections.
- Acyclovir for up to 14 days for acute herpes outbreaks.
- Documented HIV infection.
- CD4 count 50 - 300 cells/mm3.
- No active opportunistic infections.
Key exclusion criteria (31 listed)
- Clinically significant current cardiac disease, including patients who exhibit long QTC syndrome on EKG screening and who have an abnormal cardiothoracic ratio on chest x-ray at baseline.
- Active malignancy (other than cutaneous Kaposi's sarcoma or cutaneous basal cell carcinoma or in situ carcinoma of the cervix).
- Antiretroviral agents, including ddI, ddC, AZT, and d4T.
- Immunosuppressive agents.
- Investigational HIV drugs/therapies including vaccines.
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 |
|---|---|---|
| Vesnarinone | 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Vesnarinone in people with HIV Infections, run by Otsuka America Pharmaceutical at 1 site in United States.
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 9 inclusion and 31 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.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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.