HIV InfectionsPhase 1NCT00002194
An Open-Label Study in HIV+ Patients to Determine the Effects of Nevirapine (Viramune) on the Pharmacokinetics of Clarithromycin and Activity of Cytochrome 3A4.
A Phase 1 study testing Erythromycin, Nevirapine and Clarithromycin in people with HIV Infections, run by Boehringer Ingelheim at 1 site in United States.
Trial summary
To evaluate the potential pharmacokinetic interaction between nevirapine and clarithromycin, and to determine the effects of nevirapine on cytochrome P450 3A4 (CYP3A4) activity in vivo. 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?
- Erythromycin, Nevirapine and Clarithromycin
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- Start not givento not given
- 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
- Concurrent Medication:
- Allowed:
- Antiretroviral drugs (i.e., zidovudine, zalcitabine, stavudine, lamivudine, didanosine, indinavir, saquinavir) provided that there has been no change in dosing of the medication > 25% within 4 weeks of study entry.
- Patients must have:
- HIV positive status.
- CD4 count >= 100 cells/mm3.
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- Prior Medication:
- Allowed:
- Patients may be on clarithromycin at study entry.
Who cannot join
- Co-existing Condition:
- Patients with the following conditions are excluded:
- Malabsorption, severe chronic diarrhea, or inability to maintain adequate oral intake.
- Concurrent Medication:
- Excluded:
- Macrolide antibiotics (erythromycin, azithromycin, dirithromycin), azole fungals (ketoconazole, fluconazole, itraconazole), rifampin, rifabutin, phenytoin, terfenadine, astemizole, cisapride, triazolam, midazolam, other non-nucleoside reverse transcriptase inhibitors, antibiotics containing clavulanic acid, and Augmentin.
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- Patients with the following prior conditions are excluded:
- History of drug allergy or known drug hypersensitivity.
- History of clinically important disease including hepatic, renal, cardiovascular, or gastrointestinal disease.
- Prior Medication:
- Excluded:
- Investigational drugs or antineoplastic agents within 12 weeks of study entry.
- Participation in a clinical trial that used ERMBY within one year of study entry.
- Systemic treatment with drugs known to be potent hepatic enzyme inducers or inhibitors (e.g., oral macrolide antibiotics, azole antifungals, cimetidine, rifampin, rifabutin, and carbamazepine) within 28 days of study entry.
- Use of protease inhibitors; ritonavir, nelfinavir, indinavir, or non-nucleoside reverse transcriptase inhibitor compounds e.g., delavirdine) within 4 weeks of study entry.
- Prior Treatment:
- Excluded:
- Radiotherapy within 12 weeks of study entry.
- Risk Behavior:
- Excluded:
- Current history (within the last year) of IVDA, ETOH, or substance abuse.
Trial locations and contacts
1 site in 1 country.
United States1 site
South Florida Bioavailability Clinic
Miami, Florida, 331813405
About this study
To evaluate the potential pharmacokinetic interaction between nevirapine and clarithromycin, and to determine the effects of nevirapine on cytochrome P450 3A4 (CYP3A4) activity in vivo.
Read the detailed description
The study is conducted in two separate groups. Patients in Group I receive clarithromycin orally for 32 days and nevirapine orally for 28 days.
Patients in Group II receive erythromycin intravenously on days 0, 14, 28, and 43 and nevirapine orally for 28 days.
- Conditions
- HIV Infections
- Being tested
- Erythromycin, Nevirapine, Clarithromycin
- Keywords
- Antibiotics, Macrolide, Clarithromycin, Nevirapine, Reverse Transcriptase Inhibitors, Cytochrome P-450, Anti-HIV Agents
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ErythromycinDrug
NevirapineDrug
ClarithromycinDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2001 (estimated)
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
- Intervention model
- Parallel groups
- Enrolment
- 36 participants
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002194
- Sponsor's protocol ID
- 200G
- Status last verified
- Aug 2002
- First submitted
- 2 Nov 1999
- Last updated
- 24 Jun 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Study in HIV+ Patients to Determine the Effects of Nevirapine (Viramune) on the Pharmacokinetics of Clarithromycin and Activity of Cytochrome 3A4.
- ClinicalTrials.gov ID
- NCT00002194
- Acronym / sponsor ID
- 200G
- Conditions
- HIV Infections
- Keywords
- Antibiotics, Macrolide, Clarithromycin, Nevirapine, Reverse Transcriptase Inhibitors, Cytochrome P-450, Anti-HIV Agents
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- First posted
- 31 Aug 2001 (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.
To evaluate the potential pharmacokinetic interaction between nevirapine and clarithromycin, and to determine the effects of nevirapine on cytochrome P450 3A4 (CYP3A4) activity in vivo.
Detailed description
The study is conducted in two separate groups. Patients in Group I receive clarithromycin orally for 32 days and nevirapine orally for 28 days.
Patients in Group II receive erythromycin intravenously on days 0, 14, 28, and 43 and nevirapine orally for 28 days.
Study design
- Primary purpose
- Treatment
- Intervention model
- Parallel groups
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Antiretroviral drugs (i.e., zidovudine, zalcitabine, stavudine, lamivudine, didanosine, indinavir, saquinavir) provided that there has been no change in dosing of the medication > 25% within 4 weeks of study entry.
- HIV positive status.
- CD4 count >= 100 cells/mm3.
- Patients may be on clarithromycin at study entry.
Key exclusion criteria (21 listed)
- Malabsorption, severe chronic diarrhea, or inability to maintain adequate oral intake.
- Macrolide antibiotics (erythromycin, azithromycin, dirithromycin), azole fungals (ketoconazole, fluconazole, itraconazole), rifampin, rifabutin, phenytoin, terfenadine, astemizole, cisapride, triazolam, midazolam, other non-nucleoside reverse transcriptase inhibitors, antibiotics containing clavulanic acid, and Augmentin.
- History of drug allergy or known drug hypersensitivity.
- History of clinically important disease including hepatic, renal, cardiovascular, or gastrointestinal disease.
- Investigational drugs or antineoplastic agents within 12 weeks of study entry.
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 |
|---|---|---|
| Erythromycin | Drug | – |
| Nevirapine | Drug | – |
| Clarithromycin | Drug | – |
Primary outcome
Not reported in the source record.
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 24 Jun 2005.
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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.
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 Erythromycin, Nevirapine and Clarithromycin in people with HIV Infections, run by Boehringer Ingelheim 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 9 inclusion and 21 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 24 Jun 2005. 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.
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 24 Jun 2005.