HIV InfectionsPhase 1NCT00002196
A Study of CI-1012 in HIV-Infected Patients
A Phase 1 study testing CI-1012 in people with HIV Infections, run by Parke-Davis at 4 sites in United States.
Trial summary
The purpose of this study is to see if it is safe and effective to give CI-1012 to HIV-infected patients who do not have any symptoms of the disease. This study also examines how the body handles CI-1012. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- HIV Infections
- What is being tested?
- CI-1012
- How many people
- 32 participants
- Where
- 4 sitesUnited 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients must have:
- Serologic evidence of infection with HIV-1.
- CD4+ cell count >= 200 cells/mm3.
- HIV-1 RNA >= 10,000 copies/ml.
Who cannot join
- Co-existing Condition:
- Patients with the following conditions are excluded:
- Viral, fungal, or bacterial infection requiring therapy other than topical medications.
- Concurrent Medication:
- Excluded:
- Prophylactic systematic antibacterial, antifungal or antiviral agents.
Show all 13Show fewer
- Antiretroviral therapy. NOTE:
- Patient must be willing to remain off antiretroviral therapy for 1 week after completing study medication.
- Prior Medication:
- Excluded:
- Experimental therapy for >= 4 weeks prior to initiation of study medication.
- Antiretroviral treatment for 3 weeks prior to initiation of study medication.
- Systemic steroids or anticancer agents for 4 weeks prior to initiation of study medication.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Natl Institutes of Health
Bethesda, Maryland, 20892
Central Florida Research Initiative
Maitland, Florida, 32751
ViRx Inc
Palm Springs, California, 92262
ViRx Inc
San Francisco, California, 94109
About this study
Official title: A Phase I Multiple Oral, Rising-Dose, Tolerance and Pharmacokinetic Trial of CI-1012 in HIV-1-Infected Volunteers.
The purpose of this study is to see if it is safe and effective to give CI-1012 to HIV-infected patients who do not have any symptoms of the disease. This study also examines how the body handles CI-1012.
Read the detailed description
Patients receive 2 weeks of oral CI-1012 therapy in this open-label study, with 8 patients entered at each dose level studied.
- Conditions
- HIV Infections
- Being tested
- CI-1012
- Keywords
- Dose-Response Relationship, Drug, Administration, Oral, Drug Administration Schedule, CD4 Lymphocyte Count, 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.
CI-1012Drug
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
- Enrolment
- 32 participants
Sponsor and investigators
- Lead sponsor
- Parke-Davis
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002196
- Sponsor's protocol ID
- 278A
- Other IDs
- 1012-005
- Status last verified
- Jul 1998
- 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 Multiple Oral, Rising-Dose, Tolerance and Pharmacokinetic Trial of CI-1012 in HIV-1-Infected Volunteers.
- ClinicalTrials.gov ID
- NCT00002196
- Acronym / sponsor ID
- 278A
- Conditions
- HIV Infections
- Keywords
- Dose-Response Relationship, Drug, Administration, Oral, Drug Administration Schedule, CD4 Lymphocyte Count, Anti-HIV Agents
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants
- Lead sponsor
- Parke-DavisIndustry (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.
The purpose of this study is to see if it is safe and effective to give CI-1012 to HIV-infected patients who do not have any symptoms of the disease. This study also examines how the body handles CI-1012.
Detailed description
Patients receive 2 weeks of oral CI-1012 therapy in this open-label study, with 8 patients entered at each dose level studied.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Serologic evidence of infection with HIV-1.
- CD4+ cell count >= 200 cells/mm3.
- HIV-1 RNA >= 10,000 copies/ml.
Key exclusion criteria (13 listed)
- Viral, fungal, or bacterial infection requiring therapy other than topical medications.
- Prophylactic systematic antibacterial, antifungal or antiviral agents.
- Antiretroviral therapy. NOTE:
- Patient must be willing to remain off antiretroviral therapy for 1 week after completing study medication.
- Experimental therapy for >= 4 weeks prior to initiation of study medication.
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 |
|---|---|---|
| CI-1012 | 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.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CI-1012 in people with HIV Infections, run by Parke-Davis at 4 sites 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 4 inclusion and 13 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 4 sites 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.