HIV InfectionsPhase 1NCT02182791
Investigation of the Potential Pharmacokinetic Interaction Between Nevirapine (VIRAMUNE) and Ethinyl Estradiol/Norethindrone in HIV-1 Infected Women
A Phase 1 study testing Nevirapine and EE/NET in people with HIV Infections, run by Boehringer Ingelheim.
Trial summary
Study to determine the effects of nevirapine treatment on the pharmacokinetics of ethinyl estradiol (EE)/norethindrone (NET). Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- HIV Infections
- What is being tested?
- Nevirapine and EE/NET
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- No sites listed yet
- Study dates
- Apr 1998to Apr 1999
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female patients between the ages of 18 and 65 years
- Plasma HIV-1 RNA <= 400 copies/mL, documenting HIV-1 infection, within 28 days prior to Study Day 0
- Lymphocytes Expressing CD4+ Surface Marker (CD4+ cell count) >= 100 cells/mm³ within 28 days prior to Study Day 0
- Patients who meet the following laboratory parameter:
- Lymphocyte count >= 1000 cells/mm³
- Hemoglobin >= 9.0 g/dl (men and women)
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- Platelet count >= 75000 cells/mm3
- Alkaline Phosphatase <= 3.0 times the upper limit of normal
- Serum Glutamic-Oxaloacetic Transaminase (SGOT) and Serum Glutamic-Pyruvic Transaminase (SGPT) <= 3.0 times the upper limit of normal
- Total bilirubin <= 1.5 times the upper limit of normal
- Creatinine <= 2mg/dL
- Female patients of reproductive potential must be willing to use a reliable method of double-barrier contraception (such as diaphragm with spermicidal cream or jelly, or condoms with spermicidal foam)
- Patients who are informed of and willing and able to comply with the investigational nature of the study and had signed a written consent in accordance with institutional and federal guidelines
- Patients who have been on stable antiretroviral therapy (no changes in medication or dose) for at least thirty days prior to study entry and who will continue on background during study participation
Who cannot join
- Female patients who are pregnant or breast-feeding
- Patients requiring systemic treatment with corticosteroids or drugs known to be hepatic enzyme inducers or inhibitors within 14 days of stud entry (Study Day 0). Such substances in these categories include: macrolide antibiotics (erythromycin, clarithromycin), azole antifungals (ketoconazole, fluconazole, itraconazole) rifampin, rifabutin, and phenytoin
- Patients receiving any investigational drug within 30 days of the first dose of study medication and any antineoplastic agent or radiotherapy other than local skin radiotherapy treatment within 12 weeks before starting study medication
- Patients with malabsorption, severe chronic diarrhea or patients unable to maintain adequate oral intake
- Patients with a history of intravenous drug abuse, alcohol or substance abuse considered by the Investigator and Boehringer Ingelheim Pharmaceutical Incorporated (BIPI) Medical Monitor to be a significant impairment to health and compliance
- Patients undergoing treatment for an active infection
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- Patients with hepatic insufficiency due to cirrhosis
- Patients with renal insufficiency
- Patients who are heavy smokers (e.g. > 20 cigarettes per day)
- Patients currently taking Norvir® (Ritonavir) or Rescriptor® (Delavirdine)
About this study
Official title: An Investigation of the Potential Pharmacokinetic Interaction Between Nevirapine (VIRAMUNE® ) and Ethinyl Estradiol/Norethindrone [ORTHO-NOVUM® 1/35 (21 Pack)] in HIV-1 Infected Women
Study to determine the effects of nevirapine treatment on the pharmacokinetics of ethinyl estradiol (EE)/norethindrone (NET).
- Conditions
- HIV Infections
- Being tested
- Nevirapine, EE/NET
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NevirapineDrug
EE/NETDrug
| Study group | Role | What they receive |
|---|---|---|
| Nevirapine tablets | Experimental | once a day (q.d.) Day 2-15,
twice a day (b.i.d.) Study day 16-30 Receives: Drug: Nevirapine |
| EE/NET tablets | Active comparator | Single dose on Study Day 0 and 30 Receives: Drug: EE/NET |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC (Area under the plasma concentration time curve) of ethinyl estradiol/norethindrone (EE/NET)
Measured: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 15, 24, and 34 hours post dose on day 0 and day 30
Cmax (maximum observed concentration) of EE/NET
Measured: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 15, 24, and 34 hours post dose on day 0 and day 30
Tmax (Time of maximum concentration) of EE/NET
Measured: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 15, 24, and 34 hours post dose on day 0 and day 30
AUCss (Area under the concentration time curve at steady state) of nevirapine
Measured: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 15, 24, and 34 hours post dose on day 30
Cmax (maximum observed concentration) of nevirapine
Measured: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 15, 24, and 34 hours post dose on day 30
Cmin (minimum observed concentration) of nevirapine
Measured: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 15, 24, and 34 hours post dose on day 30
Cl/F (Oral clearance) of nevirapine
Measured: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 15, 24, and 34 hours post dose on day 30
Secondary outcomes (1)
Number of patients with adverse events
Measured: up to 59 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2014 (estimated)
- Study startApr 1998
- Primary completionApr 1999
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
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02182791
- Sponsor's protocol ID
- 1100.1245
- Status last verified
- Jul 2014
- First submitted
- 3 Jul 2014
- Last updated
- 14 Jul 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Investigation of the Potential Pharmacokinetic Interaction Between Nevirapine (VIRAMUNE® ) and Ethinyl Estradiol/Norethindrone [ORTHO-NOVUM® 1/35 (21 Pack)] in HIV-1 Infected Women
- ClinicalTrials.gov ID
- NCT02182791
- Acronym / sponsor ID
- 1100.1245
- Conditions
- HIV Infections
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Apr 1998
- Primary completion
- Apr 1999 (actual)
- First posted
- 8 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 to determine the effects of nevirapine treatment on the pharmacokinetics of ethinyl estradiol (EE)/norethindrone (NET).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nevirapine tablets | Experimental | Drug: Nevirapineonce a day (q.d.) Day 2-15, twice a day (b.i.d.) Study day 16-30 |
| EE/NET tablets | Active comparator | Drug: EE/NETSingle dose on Study Day 0 and 30 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Female patients between the ages of 18 and 65 years
- Plasma HIV-1 RNA <= 400 copies/mL, documenting HIV-1 infection, within 28 days prior to Study Day 0
- Lymphocytes Expressing CD4+ Surface Marker (CD4+ cell count) >= 100 cells/mm³ within 28 days prior to Study Day 0
- Patients who meet the following laboratory parameter:
- Female patients of reproductive potential must be willing to use a reliable method of double-barrier contraception (such as diaphragm with spermicidal cream or jelly, or condoms with spermicidal foam)
Key exclusion criteria (10 listed)
- Female patients who are pregnant or breast-feeding
- Patients requiring systemic treatment with corticosteroids or drugs known to be hepatic enzyme inducers or inhibitors within 14 days of stud entry (Study Day 0). Such substances in these categories include: macrolide antibiotics (erythromycin, clarithromycin), azole antifungals (ketoconazole, fluconazole, itraconazole) rifampin, rifabutin, and phenytoin
- Patients receiving any investigational drug within 30 days of the first dose of study medication and any antineoplastic agent or radiotherapy other than local skin radiotherapy treatment within 12 weeks before starting study medication
- Patients with malabsorption, severe chronic diarrhea or patients unable to maintain adequate oral intake
- Patients with a history of intravenous drug abuse, alcohol or substance abuse considered by the Investigator and Boehringer Ingelheim Pharmaceutical Incorporated (BIPI) Medical Monitor to be a significant impairment to health and compliance
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 |
|---|---|---|
| Nevirapine | Drug | Nevirapine tablets |
| EE/NET | Drug | EE/NET tablets |
Primary outcome
AUC (Area under the plasma concentration time curve) of ethinyl estradiol/norethindrone (EE/NET)
Time frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 15, 24, and 34 hours post dose on day 0 and day 30
Cmax (maximum observed concentration) of EE/NET
Time frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 15, 24, and 34 hours post dose on day 0 and day 30
Tmax (Time of maximum concentration) of EE/NET
Time frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 15, 24, and 34 hours post dose on day 0 and day 30
AUCss (Area under the concentration time curve at steady state) of nevirapine
Time frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 15, 24, and 34 hours post dose on day 30
Cmax (maximum observed concentration) of nevirapine
Time frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 15, 24, and 34 hours post dose on day 30
Cmin (minimum observed concentration) of nevirapine
Time frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 15, 24, and 34 hours post dose on day 30
Cl/F (Oral clearance) of nevirapine
Time frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 15, 24, and 34 hours post dose on day 30
1 secondary outcome
Number of patients with adverse events
Time frame: up to 59 days
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 14 Jul 2014.
- Related InfoLink provided by the sponsor.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Nevirapine and EE/NET 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 14 inclusion and 10 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 14 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?
AUC (Area under the plasma concentration time curve) of ethinyl estradiol/norethindrone (EE/NET) (time frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 15, 24, and 34 hours post dose on day 0 and day 30). The study lists 7 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 14 Jul 2014.