HIV-1 InfectionPhase 2NCT01097070
A Phase 2 Study to Assess the Pharmacokinetics of Bevirimat 100 mg Tablets Given to HIV-1 Positive Patient for 15 Days
A Phase 2 study testing Bevirimat in people with HIV-1 Infection, run by Myrexis Inc. at 4 sites in United States.
Trial summary
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (behavior in the body) of bevirimat administered for 15 days to HIV-positive individuals. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV-1 Infection
- What is being tested?
- Bevirimat
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 4 sitesUnited States
- Study dates
- Nov 2008to Jan 2009
- Phase
- Phase 2
- 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
- Have documentation of HIV-1 infection in their medical records (documentation of any prior plasma viremia is acceptable).
- Have a CD4+ lymphocyte count >/= 100 cells/mm3.
- Have a screening plasma HIV-1 RNA value, measured by the Roche Amplicor assay, of <400 copies/mL.
- Be receiving an ARV therapy regimen containing at least 3 drugs which has been unchanged for at least 8 weeks prior to screening, and which is to be continued through Day 15 of the study.
- Be informed of the nature of the study and provide written informed consent.
- Be legally competent and able to communicate effectively with study personnel.
- Be able and willing to comply with outpatient visits.
Who cannot join
- Presence of any acute illness within 14 days prior to study entry.
- Presence of any AIDS-related opportunistic infection (Category C according to the CDC Classification System for HIV-1 Infection, 1993 Revised Version) that is unstable in the Investigator's opinion or diagnosed in the 30 days prior to study entry.
- Patients who are, in the opinion of the Investigator, unable to comply with the dosing schedule and protocol evaluations.
- Patients with malabsorption syndromes affecting drug absorptions (e.g. Crohn's disease, chronic pancreatitis).
- Patients with systolic blood pressure < 90 mmHg or > 160 mmHg or diastolic blood pressure < 50 mmHg or > 110 mmHg.
- A history of seizures (excluding pediatric febrile seizures) or current administration of prophylactic anti-seizure medication for the indication of seizures or seizure-related conditions.
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- A history of cerebrovascular accident (CVA) or transient ischemic attacks (TIA).
- Patients who have received radiation therapy or cytotoxic chemotherapeutic agents within 4 weeks prior to first dose of study drug.
- Patients who have received treatment with immunomodulating agents such as IL-2, alpha-interferon, beta-interferon, or gamma-interferon within 4 weeks prior to first dose of study drug.
- Receipt of an investigational drug or product, or participation in a drug study within a period of 30 days prior to receiving study medication.
- Bupropion-containing products require at least a 14-day washout period and will not be approved for co-administration.
- Rifampin or other rifamycin products require at least a 28-day washout period and will not be approved for coadministration.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
AIDS Research Consortium of Atlanta
Atlanta, Georgia, 30308
Community Research Initiative of New England
Boston, Massachusetts, 02215
Gary J. Richmond, MD, PA
Fort Lauderdale, Florida, 33316
Quest Clinical Research
San Francisco, California, 94115
About this study
Official title: A Phase II Multicenter, Open-label, Randomized, Parrallel Group Study to Assess the Pharmacokinetics of Bevirimat (BVM) 100 mg Tablets Administered to HIV-1 Positive Patients for 15 Days
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (behavior in the body) of bevirimat administered for 15 days to HIV-positive individuals.
- Conditions
- HIV-1 Infection
- Being tested
- Bevirimat
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BevirimatDrug
Also called MPC-4326
| Study group | Role | What they receive |
|---|---|---|
| Bevirimat 200 mg twice daily, 15 days | Experimental | Not described Receives: Drug: Bevirimat |
| Bevirimat 300 mg once daily, 15 days | Experimental | Not described Receives: Drug: Bevirimat |
| Bevirimat 400 mg once daily, 15 days | Experimental | Not described Receives: Drug: Bevirimat |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure bevirimat blood plasma concentrations to calculate the pharmacokinetic parameters of AUC, Cmax, Cmin, and half-life when bevirimat is administered as 2 x 100 mg tablets BID, 3 X 100 mg tablets QD, 4 X 100 mg tablets QD for 15 days
Measured: 16 days
Secondary outcomes (1)
Measure bevirimat blood plasma concentrations following the administration of bevirimat 2 X 100 mg, 3 x 100 mg, or 4 x 100 mg tablets after a standardized meal. The pharmacokinetic parameters of AUC, Cmax, Cmin, and half-life will be calculated.
Measured: Day 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2010 (estimated)
- Study startNov 2008
- Primary completionJan 2009
- Study completionJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV-1 InfectionStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Myrexis Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Andrew Beelen, MD, Study director, Myrexis Inc.Jacob P Lalezari, MD, Principal investigator, Quest Clinical ResearchGary J Richmond, MD, PA, Principal investigatorMelanie A Thompson, MD, Principal investigator, AIDS Research Consortium of AtlantaCalvin J Cohen, MD, MSc, Principal investigator, Community Research Initiative of New England
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01097070
- Sponsor's protocol ID
- Bevirimat Study 206
- Status last verified
- Mar 2010
- First submitted
- 23 Mar 2010
- Last updated
- 1 Apr 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Multicenter, Open-label, Randomized, Parrallel Group Study to Assess the Pharmacokinetics of Bevirimat (BVM) 100 mg Tablets Administered to HIV-1 Positive Patients for 15 Days
- ClinicalTrials.gov ID
- NCT01097070
- Acronym / sponsor ID
- Bevirimat Study 206
- Conditions
- HIV-1 Infection
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Myrexis Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2008
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 1 Apr 2010 (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 evaluate the safety, tolerability, and pharmacokinetics (behavior in the body) of bevirimat administered for 15 days to HIV-positive individuals.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Bevirimat 200 mg twice daily, 15 days | Experimental | Drug: Bevirimat |
| Bevirimat 300 mg once daily, 15 days | Experimental | Drug: Bevirimat |
| Bevirimat 400 mg once daily, 15 days | Experimental | Drug: Bevirimat |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Have documentation of HIV-1 infection in their medical records (documentation of any prior plasma viremia is acceptable).
- Have a CD4+ lymphocyte count >/= 100 cells/mm3.
- Have a screening plasma HIV-1 RNA value, measured by the Roche Amplicor assay, of <400 copies/mL.
- Be receiving an ARV therapy regimen containing at least 3 drugs which has been unchanged for at least 8 weeks prior to screening, and which is to be continued through Day 15 of the study.
- Be informed of the nature of the study and provide written informed consent.
Key exclusion criteria (12 listed)
- Presence of any acute illness within 14 days prior to study entry.
- Presence of any AIDS-related opportunistic infection (Category C according to the CDC Classification System for HIV-1 Infection, 1993 Revised Version) that is unstable in the Investigator's opinion or diagnosed in the 30 days prior to study entry.
- Patients who are, in the opinion of the Investigator, unable to comply with the dosing schedule and protocol evaluations.
- Patients with malabsorption syndromes affecting drug absorptions (e.g. Crohn's disease, chronic pancreatitis).
- Patients with systolic blood pressure < 90 mmHg or > 160 mmHg or diastolic blood pressure < 50 mmHg or > 110 mmHg.
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 |
|---|---|---|
| BevirimatAlso: MPC-4326 | Drug | Bevirimat 200 mg twice daily, 15 days, Bevirimat 300 mg once daily, 15 days, Bevirimat 400 mg once daily, 15 days |
Primary outcome
Measure bevirimat blood plasma concentrations to calculate the pharmacokinetic parameters of AUC, Cmax, Cmin, and half-life when bevirimat is administered as 2 x 100 mg tablets BID, 3 X 100 mg tablets QD, 4 X 100 mg tablets QD for 15 days
Time frame: 16 days
1 secondary outcome
Measure bevirimat blood plasma concentrations following the administration of bevirimat 2 X 100 mg, 3 x 100 mg, or 4 x 100 mg tablets after a standardized meal. The pharmacokinetic parameters of AUC, Cmax, Cmin, and half-life will be calculated.
Time frame: Day 15
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 1 Apr 2010.
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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.
Andrew Beelen, MD study director
Myrexis Inc.
Jacob P Lalezari, MD principal investigator
Quest Clinical Research
Gary J Richmond, MD, PA principal investigator
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Bevirimat in people with HIV-1 Infection, run by Myrexis Inc. 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 7 inclusion and 12 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 1 Apr 2010. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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.
What does the primary outcome measure?
Measure bevirimat blood plasma concentrations to calculate the pharmacokinetic parameters of AUC, Cmax, Cmin, and half-life when bevirimat is administered as 2 x 100 mg tablets BID, 3 X 100 mg tablets QD, 4 X 100 mg tablets QD for 15 days (time frame: 16 days). It is what the study was designed to measure, not a finding.
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 1 Apr 2010.