HIV InfectionPhase 1NCT00352066
Pharmacokinetics of Apricitabine and Tipranavir When Dosed Alone or Together
A Phase 1 study testing apricitabine in people with HIV Infection, run by Avexa at 1 site in United States.
Trial summary
The aim of the study is to see if apricitabine or tipranavir affect the levels of each other in the blood (pharmacokinetic interaction) when they are dosed together. Read more about this study
- Who is it for?
- Ages 18 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- HIV Infection
- What is being tested?
- apricitabine
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2006to Aug 2006
- 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 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy males 18-40 years old
- non-smokers
- no clinically significant medical history
Who cannot join
- current or relevant previous medical history of significance
- hepatitis B, hepatitis C, or HIV positive
- current use of prescription or OTC medications
- use of illicit substances or alcohol (>14 drinks/week)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I, Open Label, Controlled, Intra-subject Comparison Study to Investigate the Effect of Co-administration Upon the Pharmacokinetics of Tipranavir (Ritonavir Boosted) and Apricitabine.
The aim of the study is to see if apricitabine or tipranavir affect the levels of each other in the blood (pharmacokinetic interaction) when they are dosed together.
Read the detailed description
Apricitabine is a new NRTI in development for treatment of drug resistant HIV. Tipranavir is a recently licensed protease inhibitor for treatment of drug resistant HIV. Tipranavir affects the plasma concentration of some other drugs when they are used together with tipranavir. This study will examine whether the pharmacokinetics of apricitabine are changed when it is dosed together with tipranavir compared to apricitabine alone. Also, the pharmacokinetics of tipranavir will be examined at steady state when it is dosed alone and when it is dosed together with apricitabine. Information on the safety and tolerability of the two drugs when dosed together will also be obtained.
- Conditions
- HIV Infection
- Being tested
- apricitabine
- Keywords
- Human Immunodeficiency Virus, anti-retroviral therapy, nucleoside analogue, reverse transcriptase, apricitabine, tipranavir, bioequivalence, drug-drug interaction, pharmacokinetics
- 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.
apricitabineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the single dose pharmacokinetics of apricitabine when administered alone and in the presence of steady state concentrations of tipranavir 500 mg administered twice daily in combination with ritonavir 200 mg twice daily.
Measured: day 1 and day 10
Secondary outcomes (2)
To compare the steady state pharmacokinetics of tipranavir 500 mg administered twice daily with ritonavir 200mg in the presence and absence of apricitabine.
Measured: day 9 and day 10
To evaluate the safety and tolerability of apricitabine administered in combination with tipranavir and ritonavir.
Measured: day 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2006 (estimated)
- Study startJul 2006
- Primary completionAug 2006
- Study completionAug 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV 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 1
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Avexa
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Susan W Cox, Ph D, Study director, Avexa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00352066
- Sponsor's protocol ID
- AVX-102
- Status last verified
- Jun 2011
- First submitted
- 12 Jul 2006
- Last updated
- 23 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Open Label, Controlled, Intra-subject Comparison Study to Investigate the Effect of Co-administration Upon the Pharmacokinetics of Tipranavir (Ritonavir Boosted) and Apricitabine.
- ClinicalTrials.gov ID
- NCT00352066
- Acronym / sponsor ID
- AVX-102
- Conditions
- HIV Infection
- Keywords
- Human Immunodeficiency Virus, anti-retroviral therapy, nucleoside analogue, reverse transcriptase, apricitabine, tipranavir, bioequivalence, drug-drug interaction
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- AvexaIndustry (pharma, biotech, devices)
- Study start
- Jul 2006
- Primary completion
- Aug 2006 (actual)
- Study completion
- Aug 2006 (actual)
- First posted
- 14 Jul 2006 (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 aim of the study is to see if apricitabine or tipranavir affect the levels of each other in the blood (pharmacokinetic interaction) when they are dosed together.
Detailed description
Apricitabine is a new NRTI in development for treatment of drug resistant HIV. Tipranavir is a recently licensed protease inhibitor for treatment of drug resistant HIV. Tipranavir affects the plasma concentration of some other drugs when they are used together with tipranavir. This study will examine whether the pharmacokinetics of apricitabine are changed when it is dosed together with tipranavir compared to apricitabine alone. Also, the pharmacokinetics of tipranavir will be examined at steady state when it is dosed alone and when it is dosed together with apricitabine. Information on the safety and tolerability of the two drugs when dosed together will also be obtained.
Study design
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- healthy males 18-40 years old
- non-smokers
- no clinically significant medical history
Key exclusion criteria (4 listed)
- current or relevant previous medical history of significance
- hepatitis B, hepatitis C, or HIV positive
- current use of prescription or OTC medications
- use of illicit substances or alcohol (>14 drinks/week)
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 |
|---|---|---|
| apricitabine | Drug | – |
Primary outcome
To compare the single dose pharmacokinetics of apricitabine when administered alone and in the presence of steady state concentrations of tipranavir 500 mg administered twice daily in combination with ritonavir 200 mg twice daily.
Time frame: day 1 and day 10
2 secondary outcomes
To compare the steady state pharmacokinetics of tipranavir 500 mg administered twice daily with ritonavir 200mg in the presence and absence of apricitabine.
Time frame: day 9 and day 10
To evaluate the safety and tolerability of apricitabine administered in combination with tipranavir and ritonavir.
Time frame: day 10
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 23 Jun 2011.
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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.
Susan W Cox, Ph D study director
Avexa
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 apricitabine in people with HIV Infection, run by Avexa 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 3 inclusion and 4 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 23 Jun 2011. 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.
What does the primary outcome measure?
To compare the single dose pharmacokinetics of apricitabine when administered alone and in the presence of steady state concentrations of tipranavir 500 mg administered twice daily in combination with ritonavir 200 mg twice daily. (time frame: day 1 and day 10). 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 23 Jun 2011.