HIV InfectionsPhase 1NCT02182765
Investigation of the Potential Pharmacokinetic Interaction Between Nevirapine, Abacavir and Amprenavir in HIV-1 Infected Non-Nucleoside Reverse Transcriptase Inhibitor (NNRTI) Naive Adults
A Phase 1 study testing Nevirapine, Amprenavir and Abacavir in people with HIV Infections, run by Boehringer Ingelheim.
Trial summary
Study to determine the effects of 28 days of nevirapine treatment on the steady-state pharmacokinetics of amprenavir and of abacavir and to further evaluate the pharmacokinetics of nevirapine in combination with amprenavir and abacavir compared to historical controls treated with nevirapine but without amprenavir or… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- HIV Infections
- What is being tested?
- Nevirapine, Amprenavir and Abacavir
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- No sites listed yet
- Study dates
- Apr 1999to Jul 2001
- 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
- Male or female patients between the ages of 18 and 65 years, inclusive;
- Plasma HIV-1 RNA >= 5000 copies/mL, documenting HIV-1 infection
- CD4+ cell count >= 100 cells/mm³
- Patients who met 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 had to 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 were 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
Who cannot join
- Female patients who were pregnant or breast-feeding
- Female patients who intended to change their double-barrier contraception method within 28 days prior to Study Day 0 and throughout the trial
- Patients who in the opinion of the investigator required treatment with a prohibited medication during the study including the potentially toxic substrates such as terfenadine, bepridil, astemizole, cisapride, triazolam, midazolam and ergotamine/dihydroergotamine containing regimes
- Patients taking known inhibitors or inducers of Cytochrome P450 metabolic enzymes including macrolide antibiotics (erythromycin, clarithromycin, azithromycin) azole antifungals (fluconazole, itraconazole) and phenytoin within 28 days prior or Study day 0 and throughout the trial
- Patients receiving immunomodulatory agents
- Ketoconazole, rifabutin and rifampin were excluded during screening and throughout the trial
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- Patients with previous exposure to anti-retroviral, such as delavirdine, loviride, efavirenz, nevirapine, abacavir, saquinavir, ritonavir, indinavir, nelfinavir, amprenavir, zidovudine, Lamivudine (3TC), Stavudine (d4T), Didanosine (ddI) and Zalcitabine (ddC)
- Patients receiving any investigational drug or systemic corticosteroids within 30 days of the first dose of study medication and system corticosteroids initially as well as throughout the study and any antineoplastic agent of 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 currently abusing alcohol or substance abusing; patients on methadone substitution programs might be considered for inclusion in the trial
- Patients undergoing treatment for an active infection
- Patients with hepatic insufficiency due to cirrhosis
- Patients with renal insufficiency
- Patients who were heavy smokers (e.g. > 20 cigarettes per day)
- Patients whose reliability was deemed to put them at risk for non-compliance with the study
About this study
Official title: An Investigation of the Potential Pharmacokinetic Interaction Between Nevirapine (VIRAMUNE®), Abacavir and Amprenavir in HIV-1 Infected NNRTI Naive Adults
Study to determine the effects of 28 days of nevirapine treatment on the steady-state pharmacokinetics of amprenavir and of abacavir and to further evaluate the pharmacokinetics of nevirapine in combination with amprenavir and abacavir compared to historical controls treated with nevirapine but without amprenavir or abacavir. In addition safety/tolerance of nevirapine, amprenavir and abacavir was to be assessed based on adverse events and clinical laboratory data.
- Conditions
- HIV Infections
- Being tested
- Nevirapine, Amprenavir, Abacavir
- 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
AmprenavirDrug
AbacavirDrug
| Study group | Role | What they receive |
|---|---|---|
| Nevirapine | Experimental | Part I: Study days 15-43
Part II: Study day 44 to end of trial Receives: Drug: Nevirapine |
| Amprenavir | Active comparator | Part I: Study days 0 to 43
Part II: Study day 44 to end of trial Receives: Drug: Amprenavir |
| Abacavir | Active comparator | Part I: Study days 0 to 43
Part II Study day 44 to end of trial Receives: Drug: Abacavir |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC (area under plasma concentration time curve) of amprenavir in the absence and presence of nevirapine
Measured: Day 14, day 43
Cmax (maximum observed concentration of the analyte in plasma) of amprenavir in the absence and presence of nevirapine
Measured: Day 14, day 43
AUC (area under plasma concentration time curve) of abacavir in the absence and presence of nevirapine
Measured: Day 14, day 43
Cmax (maximum observed concentration of the analyte in plasma) of abacavir in the absence and presence of nevirapine
Measured: Day 14, day 43
Secondary outcomes (5)
Change from baseline in HIV-1 Ribonucleic Acid (RNA)
Measured: Baseline, day 14, 21, 28, 35, 43 (Part I), up to 168 days (Part II)
Change from baseline in Lymphocytes Expressing CD4+ cell count
Measured: Baseline, day 14, 21, 28, 35, 43 (Part I), up to 168 days (Part II)
Proportion of patients who achieved RNA levels below limit of quantification (BLoQ) (responders)
Measured: up to 43 days (Part I), up to 168 days (Part II)
Number of patients with adverse events
Measured: up to 240 days
Number of patients with abnormal changes in laboratory parameters
Measured: Baseline, day 14, 28, 43 (Part I), up to 168 days (Part II)
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 1999
- Primary completionJul 2001
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
- 8 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
- NCT02182765
- Sponsor's protocol ID
- 1100.1244
- 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®), Abacavir and Amprenavir in HIV-1 Infected NNRTI Naive Adults
- ClinicalTrials.gov ID
- NCT02182765
- Acronym / sponsor ID
- 1100.1244
- Conditions
- HIV Infections
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Apr 1999
- Primary completion
- Jul 2001 (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 28 days of nevirapine treatment on the steady-state pharmacokinetics of amprenavir and of abacavir and to further evaluate the pharmacokinetics of nevirapine in combination with amprenavir and abacavir compared to historical controls treated with nevirapine but without amprenavir or abacavir. In addition safety/tolerance of nevirapine, amprenavir and abacavir was to be assessed based on adverse events and clinical laboratory data.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Nevirapine | Experimental | Drug: NevirapinePart I: Study days 15-43 Part II: Study day 44 to end of trial |
| Amprenavir | Active comparator | Drug: AmprenavirPart I: Study days 0 to 43 Part II: Study day 44 to end of trial |
| Abacavir | Active comparator | Drug: AbacavirPart I: Study days 0 to 43 Part II Study day 44 to end of trial |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Male or female patients between the ages of 18 and 65 years, inclusive;
- Plasma HIV-1 RNA >= 5000 copies/mL, documenting HIV-1 infection
- CD4+ cell count >= 100 cells/mm³
- Patients who met the following laboratory parameter:
- Female patients of reproductive potential had to 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 (15 listed)
- Female patients who were pregnant or breast-feeding
- Female patients who intended to change their double-barrier contraception method within 28 days prior to Study Day 0 and throughout the trial
- Patients who in the opinion of the investigator required treatment with a prohibited medication during the study including the potentially toxic substrates such as terfenadine, bepridil, astemizole, cisapride, triazolam, midazolam and ergotamine/dihydroergotamine containing regimes
- Patients taking known inhibitors or inducers of Cytochrome P450 metabolic enzymes including macrolide antibiotics (erythromycin, clarithromycin, azithromycin) azole antifungals (fluconazole, itraconazole) and phenytoin within 28 days prior or Study day 0 and throughout the trial
- Patients receiving immunomodulatory agents
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 |
| Amprenavir | Drug | Amprenavir |
| Abacavir | Drug | Abacavir |
Primary outcome
AUC (area under plasma concentration time curve) of amprenavir in the absence and presence of nevirapine
Time frame: Day 14, day 43
Cmax (maximum observed concentration of the analyte in plasma) of amprenavir in the absence and presence of nevirapine
Time frame: Day 14, day 43
AUC (area under plasma concentration time curve) of abacavir in the absence and presence of nevirapine
Time frame: Day 14, day 43
Cmax (maximum observed concentration of the analyte in plasma) of abacavir in the absence and presence of nevirapine
Time frame: Day 14, day 43
5 secondary outcomes
Change from baseline in HIV-1 Ribonucleic Acid (RNA)
Time frame: Baseline, day 14, 21, 28, 35, 43 (Part I), up to 168 days (Part II)
Change from baseline in Lymphocytes Expressing CD4+ cell count
Time frame: Baseline, day 14, 21, 28, 35, 43 (Part I), up to 168 days (Part II)
Proportion of patients who achieved RNA levels below limit of quantification (BLoQ) (responders)
Time frame: up to 43 days (Part I), up to 168 days (Part II)
Number of patients with adverse events
Time frame: up to 240 days
Number of patients with abnormal changes in laboratory parameters
Time frame: Baseline, day 14, 28, 43 (Part I), up to 168 days (Part II)
Results and safety
The study was stopped early. Results are not available in the source record.
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, Amprenavir and Abacavir 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 15 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: stopped early, 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 was stopped early. Results are not available in the source record.
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 plasma concentration time curve) of amprenavir in the absence and presence of nevirapine (time frame: Day 14, day 43). The study lists 4 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.