HIV InfectionsPhase 1NCT02194179

Bioavailability of 2 Different Nevirapine Extended Release Formulations Compared to Viramune® in HIV-1 Infected Subjects

A Phase 1 study testing NVP XR 400 mg (KCR 25%), NVP XR 400 mg (KCR 20%) and NVP XR 300 mg (KCR 25%) in people with HIV Infections, run by Boehringer Ingelheim.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The objective was to establish the pharmacokinetic (PK) profile at steady state of two different nevirapine (NVP) extended release (XR) formulations at 300 mg or 400 mg daily (QD) under fasted and fed conditions in comparison with the commercially available NVP immediate release (IR) tablet at 200 mg BID (400 mg/day). 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?: NVP XR 400 mg (KCR 25%), NVP XR 400 mg (KCR 20%) and NVP XR 300 mg (KCR 25%)
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 92 participants
Where: No sites listed yet
Study dates: Dec 2006to May 2007
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

HIV-1 infected males or females ≥ 18 and ≤ 60 years of age
Body mass index 18.5 to 29.9 kg/m2, inclusive
Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice and local legislation
Treated with a stable Viramune® BID based regimen since at least 12 weeks prior to study entry. If however, the subject's current Viramune® treatment consists of two 200mg tablets once daily (prescribed off label), the subject is allowed to participate if he/she agrees to switch to Viramune® 200mg twice daily, 14 days before the start of Nevirapine Extended Release.
An HIV-1 viral load of ≤ 50 c/mL at screening
Acceptable screening laboratory values that indicate adequate baseline organ function with the following exceptions:

Show all 13Show fewer

Alanine aminotransferase (ALT) or aspartate aminotransferase (AST)
≤2.5 times the upper limit of normal (ULN) (DAIDS Grade 1) or
Gamma-glutamyl transferase (GGT) <2.5 times ULN (DAIDS Grade 1)
Willingness to abstain from alcoholic beverages for 24 hours prior to intensive pharmakokinetic sampling days
Willingness to abstain from ingesting substances which may alter drug plasma levels by interaction with the cytochrome P450 system during the study
Willingness to abstain from grapefruit and grapefruit juice, Seville oranges and juice, and St John's wort or milk thistle starting 14 days prior to administration of study medication until the end of the study, and
Karnofsky performance score ≥70

Who cannot join

Current treatment with any PI
Participation in another trial with an investigational medicine within two months prior to Day 1 of this study
Serum creatinine levels >1.5 times ULN at screening
History of acute illness within 60 days prior to Day 1, which would make the subject, in the opinion of the investigator, unsuitable for the trial
History or evidence of severe illness, malignancy or any other conditions which would make the subjects, in the opinion of the investigator, unsuitable for the trial
Any evidence of a clinically relevant concomitant disease, including gastrointestinal, hepatic, renal disorders of clinical relevance

Show all 20Show fewer

Surgery of the gastrointestinal tract (except appendectomy and herniotomy)
Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
Chronic or relevant acute infections other than HIV-1 (e.g. hepatitis B virus (HBV), hepatitis C virus (HCV) co infection: A chronic or acute HBV infections is defined as: HBs Ag positive. Chronic or acute HCV infection is defined as: HCV Ab positive and 1 confirmed positive viral load measurement preceding study entry)
Alcohol or substance abuse within 6 months prior to screening or during the study
Inability to comply with protocol requirements
Screening laboratory values <DAIDS grade 1
All fertile males or females, and their respective partner(s) not willing to use two forms of effective contraception. A double-barrier method must be used. A double-barrier method is defined as e.g.: 1) a condom with spermicidal jelly or with a foam suppository; 2) a diaphragm with spermicide; or 3) a male condom and a diaphragm
Female of child-bearing potential who:
Has a positive serum pregnancy test at screening,
Is breastfeeding,
Is planning to become pregnant, or
Is not willing to use barrier method protection or require ethinyl estradiol administration
Any AIDS-defining illness that is unresolved, symptomatic, or not stable on treatment for at least 12 weeks before the screening visit
HIV-2 infection

About this study

Official title: Steady State Bioavailability of 2 Different Nevirapine Extended Release Formulations Compared to Steady State 400 mg of Viramune® (200 mg BID), in HIV-1 Infected Subjects, an Open Label, Non Randomised, Multidose and Multistage Parallel Group Study. (ERVIR)

Conditions: HIV Infections
Being tested: NVP XR 400 mg (KCR 25%), NVP XR 400 mg (KCR 20%), NVP XR 300 mg (KCR 25%), NVP XR 300 mg (KCR 20%), high-fat breakfast
Medical subject headings: HIV Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

NVP XR 400 mg (KCR 25%)Drug
NVP XR 400 mg (KCR 20%)Drug
NVP XR 300 mg (KCR 25%)Drug
NVP XR 300 mg (KCR 20%)Drug
high-fat breakfastOther
NVP IR 200 mg (Viramune®)Drug

Study groups in NCT02194179
Study group	Role	What they receive
NVP XR 400 mg (KCR 25%) fasted	Experimental	Not described Receives: Drug: NVP XR 400 mg (KCR 25%)
NVP XR 400 mg (KCR 25%) fed	Experimental	Not described Receives: Drug: NVP XR 400 mg (KCR 25%); Other: high-fat breakfast
NVP XR 400 mg (KCR 20%) fasted	Experimental	Not described Receives: Drug: NVP XR 400 mg (KCR 20%)
NVP XR 400 mg (KCR 20%) fed	Experimental	Not described Receives: Drug: NVP XR 400 mg (KCR 20%); Other: high-fat breakfast
NVP XR 300 mg (KCR 25%) fasted	Experimental	Not described Receives: Drug: NVP XR 300 mg (KCR 25%)
NVP XR 300 mg (KCR 25%) fed	Experimental	Not described Receives: Drug: NVP XR 300 mg (KCR 25%); Other: high-fat breakfast
NVP XR 300 mg (KCR 20%) fasted	Experimental	Not described Receives: Drug: NVP XR 300 mg (KCR 20%)
NVP XR 300 mg (KCR 20%) fed	Experimental	Not described Receives: Drug: NVP XR 300 mg (KCR 20%); Other: high-fat breakfast
NVP IR 200 mg (Viramune®)	Active comparator	Not described Receives: Drug: NVP IR 200 mg (Viramune®)

What is being measured

The primary outcome is the main question the study is designed to answer.

AUCτ,ss (area under the concentration-time curve of the analyte in plasma at steady state over the time dosing interval τ)
Measured: up to day 22
Cmin,ss (minimum measured concentration of the analyte in plasma at steady state over the time dosing interval τ)
Measured: up to day 22
Cmax,ss (maximum measured concentration of the analyte in plasma at steady state over the time dosing interval τ)
Measured: up to day 22

Secondary outcomes (12)

Cmax,ss / Cmin,ss ratio
Measured: up to day 22
%PTF (percentage peak-trough fluctuation)
Measured: up to day 22
tmax,ss (time from dosing to the maximum concentration of the analyte in plasma at steady state over the time dosing interval τ)
Measured: up to day 22
CL/F,ss (apparent clearance of the analyte in the plasma after extravascular administration at steady state)
Measured: up to day 22
Cavg (average measured concentration of the analyte in plasma at steady state)
Measured: up to day 22
Number of patients with adverse events (AEs)
Measured: up to day 57
Number of patients with clinically relevant changes in clinical laboratory tests
Measured: Baseline, up to day 37
Number of patients with abnormal detectable viral load
Measured: Baseline, up to day 37
Number of patients with clinically relevant changes in vital signs (blood pressure, pulse rate)
Measured: Baseline, up to day 37
Number of patients with clinically relevant changes in 12-lead electrocardiogram (ECG)
Measured: Baseline, day 23
Number of patients with clinically relevant changes in physical examination
Measured: Baseline, up to day 37
Assessment of tolerability by the investigator on a 4-point scale
Measured: up to day 37

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2006May 2007

First posted18 Jul 2014 (estimated)
Study startDec 2006
Primary completionMay 2007

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.
More trials run by Boehringer IngelheimThe sponsor's other registered studies.
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
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 92 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02194179
Sponsor's protocol ID: 1100.1489
Status last verified: Jul 2014
First submitted: 17 Jul 2014
Last updated: 18 Jul 2014
Results posted: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Recruiting
Evaluating the Impact of Using the B-OK Bottles for HIV and ART Literacy in South Africa
HIV, HIV Treatment
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder

All HIV Infections trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Steady State Bioavailability of 2 Different Nevirapine Extended Release Formulations Compared to Steady State 400 mg of Viramune® (200 mg BID), in HIV-1 Infected Subjects, an Open Label, Non Randomised, Multidose and Multistage Parallel Group Study. (ERVIR)
ClinicalTrials.gov ID: NCT02194179
Acronym / sponsor ID: 1100.1489
Conditions: HIV Infections
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 92 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Dec 2006
Primary completion: May 2007 (actual)
First posted: 18 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.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 9

Arm	Type	Receives
NVP XR 400 mg (KCR 25%) fasted	Experimental	Drug: NVP XR 400 mg (KCR 25%)
NVP XR 400 mg (KCR 25%) fed	Experimental	Drug: NVP XR 400 mg (KCR 25%), Other: high-fat breakfast
NVP XR 400 mg (KCR 20%) fasted	Experimental	Drug: NVP XR 400 mg (KCR 20%)
NVP XR 400 mg (KCR 20%) fed	Experimental	Drug: NVP XR 400 mg (KCR 20%), Other: high-fat breakfast
NVP XR 300 mg (KCR 25%) fasted	Experimental	Drug: NVP XR 300 mg (KCR 25%)
NVP XR 300 mg (KCR 25%) fed	Experimental	Drug: NVP XR 300 mg (KCR 25%), Other: high-fat breakfast
NVP XR 300 mg (KCR 20%) fasted	Experimental	Drug: NVP XR 300 mg (KCR 20%)
NVP XR 300 mg (KCR 20%) fed	Experimental	Drug: NVP XR 300 mg (KCR 20%), Other: high-fat breakfast
NVP IR 200 mg (Viramune®)	Active comparator	Drug: NVP IR 200 mg (Viramune®)

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (13 listed)

HIV-1 infected males or females ≥ 18 and ≤ 60 years of age
Body mass index 18.5 to 29.9 kg/m2, inclusive
Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice and local legislation
Treated with a stable Viramune® BID based regimen since at least 12 weeks prior to study entry. If however, the subject's current Viramune® treatment consists of two 200mg tablets once daily (prescribed off label), the subject is allowed to participate if he/she agrees to switch to Viramune® 200mg twice daily, 14 days before the start of Nevirapine Extended Release.
An HIV-1 viral load of ≤ 50 c/mL at screening

Key exclusion criteria (20 listed)

Current treatment with any PI
Participation in another trial with an investigational medicine within two months prior to Day 1 of this study
Serum creatinine levels >1.5 times ULN at screening
History of acute illness within 60 days prior to Day 1, which would make the subject, in the opinion of the investigator, unsuitable for the trial
History or evidence of severe illness, malignancy or any other conditions which would make the subjects, in the opinion of the investigator, unsuitable for the trial

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
NVP XR 400 mg (KCR 25%)	Drug	NVP XR 400 mg (KCR 25%) fasted, NVP XR 400 mg (KCR 25%) fed
NVP XR 400 mg (KCR 20%)	Drug	NVP XR 400 mg (KCR 20%) fasted, NVP XR 400 mg (KCR 20%) fed
NVP XR 300 mg (KCR 25%)	Drug	NVP XR 300 mg (KCR 25%) fasted, NVP XR 300 mg (KCR 25%) fed
NVP XR 300 mg (KCR 20%)	Drug	NVP XR 300 mg (KCR 20%) fasted, NVP XR 300 mg (KCR 20%) fed
high-fat breakfast	Other	NVP XR 300 mg (KCR 20%) fed, NVP XR 300 mg (KCR 25%) fed, NVP XR 400 mg (KCR 20%) fed, NVP XR 400 mg (KCR 25%) fed
NVP IR 200 mg (Viramune®)	Drug	NVP IR 200 mg (Viramune®)

Primary outcome

AUCτ,ss (area under the concentration-time curve of the analyte in plasma at steady state over the time dosing interval τ)
Time frame: up to day 22
Cmin,ss (minimum measured concentration of the analyte in plasma at steady state over the time dosing interval τ)
Time frame: up to day 22
Cmax,ss (maximum measured concentration of the analyte in plasma at steady state over the time dosing interval τ)
Time frame: up to day 22

12 secondary outcomes

Cmax,ss / Cmin,ss ratio
Time frame: up to day 22
%PTF (percentage peak-trough fluctuation)
Time frame: up to day 22
tmax,ss (time from dosing to the maximum concentration of the analyte in plasma at steady state over the time dosing interval τ)
Time frame: up to day 22
CL/F,ss (apparent clearance of the analyte in the plasma after extravascular administration at steady state)
Time frame: up to day 22
Cavg (average measured concentration of the analyte in plasma at steady state)
Time frame: up to day 22
Number of patients with adverse events (AEs)
Time frame: up to day 57
Number of patients with clinically relevant changes in clinical laboratory tests
Time frame: Baseline, up to day 37
Number of patients with abnormal detectable viral load
Time frame: Baseline, up to day 37
Number of patients with clinically relevant changes in vital signs (blood pressure, pulse rate)
Time frame: Baseline, up to day 37
Number of patients with clinically relevant changes in 12-lead electrocardiogram (ECG)
Time frame: Baseline, day 23
Number of patients with clinically relevant changes in physical examination
Time frame: Baseline, up to day 37
Assessment of tolerability by the investigator on a 4-point scale
Time frame: up to day 37

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 18 Jul 2014.

Related trials for HIV Infections

Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Recruiting
Evaluating the Impact of Using the B-OK Bottles for HIV and ART Literacy in South Africa
HIV, HIV Treatment
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder

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.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing NVP XR 400 mg (KCR 25%), NVP XR 400 mg (KCR 20%) and NVP XR 300 mg (KCR 25%) in people with HIV Infections, run by Boehringer Ingelheim.

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 13 inclusion and 20 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 18 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.

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?

AUCτ,ss (area under the concentration-time curve of the analyte in plasma at steady state over the time dosing interval τ) (time frame: up to day 22). 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?

On the ClinicalTrials.gov record for NCT02194179.

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 18 Jul 2014.