HIV-1Phase 1NCT02202005
Multiple Dose BE Study With Nevirapine 400mg PR Tablets
A Phase 1 study testing Nevirapine and Viramune® in people with HIV-1, run by Ratiopharm GmbH at 1 site in United Kingdom.
Trial summary
The objective of this steady state pivotal study is to compare the rate and extent of absorption and to evaluate Bioequivalence of test drug compared to the approved reference product in HIV infected individuals Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- HIV-1
- What is being tested?
- Nevirapine and Viramune®
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Aug 2014to Aug 2015
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed and dated written informed consent prior to admission to the study
- HIV1 infected males or females of 18 to 65 years, nonsmoker (use of cannabis may be accepted)
- Body weight ≥ 50.0 kg and BMI ≥ 18.0 and ≤ 32.0 kg/m2
- Absence of clinically significant history of neurological, endocrinal, cardiovascular, pulmonary, haematological, psychiatric, gastrointestinal, renal, hepatic, obstructive disorders, cholestasis, and metabolic disease
- Treatment with a stable nevirapine based combination regimen for at least the preceding 12 weeks (or 6 weeks if switched from an antiretroviral regimen containing two nucleoside analogues and efavirenz)
- Background HIV therapy with a stable antiretroviral regimen that is recommended in combination with nevirapine according to British HIV Association clinical guidelines:
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- Abacavir and lamivudine {ABC/3TC} as fixed dose combination Kivexa
- Tenofovir and emtricitabine {TDF/FTC} Truvada
- Zidovudine and lamivudine {AZT/3TC} - Combivir, OR
- Tenofovir and lamivudine as separately prescribed components and kept constant (in combination and dosage) throughout the whole course of the study
- An HIV viral load < 50 copies/mL in preceding 3 months and at screening
- A CD4+ Tcell count > 50 cell/mm3
- Acceptable screening laboratory values that indicate adequate baseline organ function
- Willingness to abstain from ingesting medications that are listed as contraindicated for nevirapine during the whole course of the study
- Capable of completing patient diaries
- Capable and willing to come back for PK assessments and follow up
- Willingness to refrain from excessive physical activity during the trial
- Willingness of male study participants to not father a child during and throughout the study. To prevent a pregnancy of the female partner, both the male study participant and the female partner need to take appropriate contraceptives to prevent pregnancy during the study.
Who cannot join
- Infection with HIV2 or HIV1 group O.
- Current treatment with an HIV protease inhibitor
- Participation in any other study within 30 days of Day 1, or intention to participate in another study during participation in this study.
- Male and female patients who are not willing to use male or female condoms to prevent HIV transmission
- Female patients of childbearing potential who:
- Have a positive serum pregnancy test at screening.
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- Are breast feeding.
- Are planning to become pregnant
- Are not willing to take appropriate measures to prevent pregnancy during the study
- Females who do not use an acceptable contraceptive regimen or confirm total abstinence will be allowed to participate in this study only if they are not considered to be of childbearing potential
- Laboratory parameters > DAIDS grade 2 Coagulation
- Laboratory parameters > DAIDS grade 2 Total triglycerides
- Hypersensitivity to the active substance or any ingredients of the test or reference investigational products or chemically related compounds.
- Contraindication to Nevirapine
- Relevant history or current condition, illness that might interfere with drug absorption, distribution, metabolism or excretion
- Use of concomitant medication (other than the stable background antiretroviral HIV therapy) that may interfere with the pharmacokinetics of nevirapine and/or the background antiretroviral HIV therapy)
- Intake of products containing St. John's Wort from 14 days before treatment with study medication (Day 1) and not willing to abstain from it throughout the study until after the last study visit
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Chelsea and Westminster NHS Foundation Trust
London, SW10 9TH
About this study
Official title: A Multiple Dose, Open Label, Pivotal, 4 Period, 2 Treatment, Sequence Full Replicative Crossover Study to Assess the Bioequivalence (BE) of TEVA's Generic Once Daily Nevirapine 400 mg Prolonged Release (PR) Formulation Compared With the Approved Reference Product Viramune® 400 mg Prolonged Release Tablets Under Fasted Conditions in HIV1 Infected Patients
The objective of this steady state pivotal study is to compare the rate and extent of absorption and to evaluate Bioequivalence of test drug compared to the approved reference product in HIV infected individuals
- Conditions
- HIV-1
- Being tested
- Nevirapine, Viramune®
- Keywords
- Bioequivalence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NevirapineDrug
Nevirapine 400mg PR tablet
Viramune®Drug
Viramune® 400 mg Retardtabletten
| Study group | Role | What they receive |
|---|---|---|
| Nevirapine | Experimental | Not described Receives: Drug: Nevirapine; Drug: Viramune® |
| Viramune® | Active comparator | Not described Receives: Drug: Nevirapine; Drug: Viramune® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma concentrations by AUC0 τ,ss (area under the concentration time curve)
Measured: Days 14, 28, 42, 56
Cτ,ss (defined as concentration at the end of dosing interval)
Measured: Days 14, 28, 42, 56
Cmax,ss (maximum observed plasma concentration)
Measured: Days 14, 28, 42, 56
Secondary outcomes (4)
Percentage of fluctuation over one dosing interval at steady state (Fl(%)
Measured: Days 14, 28, 42, 56
Tmax,ss (the time to maximum plasma concentration at steady state)
Measured: Days 14, 28, 42, 56
Cmin,ss (minimum plasma concentration at steady state)
Measured: Days 14, 28, 42, 56
Average plasma drug concentration
Measured: Days 14, 28, 42, 56
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2014 (estimated)
- Study startAug 2014
- Primary completionJul 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV-1Studies 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ratiopharm GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Teva Medical Expert, MD, Principal investigator, Chelsea and Westminster NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02202005
- Sponsor's protocol ID
- NEVIR5U14EU
- Other IDs
- 2014-002247-18, 2014
- Status last verified
- Aug 2015
- First submitted
- 24 Jul 2014
- Last updated
- 25 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multiple Dose, Open Label, Pivotal, 4 Period, 2 Treatment, Sequence Full Replicative Crossover Study to Assess the Bioequivalence (BE) of TEVA's Generic Once Daily Nevirapine 400 mg Prolonged Release (PR) Formulation Compared With the Approved Reference Product Viramune® 400 mg Prolonged Release Tablets Under Fasted Conditions in HIV1 Infected Patients
- ClinicalTrials.gov ID
- NCT02202005
- Acronym / sponsor ID
- NEVIR5U14EU
- Conditions
- HIV-1
- Keywords
- Bioequivalence
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Ratiopharm GmbHIndustry (pharma, biotech, devices)
- Study start
- Aug 2014
- Primary completion
- Jul 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 28 Jul 2014 (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 objective of this steady state pivotal study is to compare the rate and extent of absorption and to evaluate Bioequivalence of test drug compared to the approved reference product in HIV infected individuals
Study design
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nevirapine | Experimental | Drug: Nevirapine, Drug: Viramune® |
| Viramune® | Active comparator | Drug: Nevirapine, Drug: Viramune® |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Signed and dated written informed consent prior to admission to the study
- HIV1 infected males or females of 18 to 65 years, nonsmoker (use of cannabis may be accepted)
- Body weight ≥ 50.0 kg and BMI ≥ 18.0 and ≤ 32.0 kg/m2
- Absence of clinically significant history of neurological, endocrinal, cardiovascular, pulmonary, haematological, psychiatric, gastrointestinal, renal, hepatic, obstructive disorders, cholestasis, and metabolic disease
- Treatment with a stable nevirapine based combination regimen for at least the preceding 12 weeks (or 6 weeks if switched from an antiretroviral regimen containing two nucleoside analogues and efavirenz)
Key exclusion criteria (17 listed)
- Infection with HIV2 or HIV1 group O.
- Current treatment with an HIV protease inhibitor
- Participation in any other study within 30 days of Day 1, or intention to participate in another study during participation in this study.
- Male and female patients who are not willing to use male or female condoms to prevent HIV transmission
- Female patients of childbearing potential who:
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 |
|---|---|---|
| NevirapineNevirapine 400mg PR tablet | Drug | Nevirapine, Viramune® |
| Viramune®Viramune® 400 mg Retardtabletten | Drug | Nevirapine, Viramune® |
Primary outcome
Plasma concentrations by AUC0 τ,ss (area under the concentration time curve)
Time frame: Days 14, 28, 42, 56
Cτ,ss (defined as concentration at the end of dosing interval)
Time frame: Days 14, 28, 42, 56
Cmax,ss (maximum observed plasma concentration)
Time frame: Days 14, 28, 42, 56
4 secondary outcomes
Percentage of fluctuation over one dosing interval at steady state (Fl(%)
Time frame: Days 14, 28, 42, 56
Tmax,ss (the time to maximum plasma concentration at steady state)
Time frame: Days 14, 28, 42, 56
Cmin,ss (minimum plasma concentration at steady state)
Time frame: Days 14, 28, 42, 56
Average plasma drug concentration
Time frame: Days 14, 28, 42, 56
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 25 Aug 2015.
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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.
Teva Medical Expert, MD principal investigator
Chelsea and Westminster NHS Foundation Trust
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 Nevirapine and Viramune® in people with HIV-1, run by Ratiopharm GmbH at 1 site in United Kingdom.
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 18 inclusion and 17 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 25 Aug 2015. 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 Kingdom. 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?
Plasma concentrations by AUC0 τ,ss (area under the concentration time curve) (time frame: Days 14, 28, 42, 56). The study lists 3 primary outcomes in all. 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 25 Aug 2015.