HIV InfectionsPhase 1NCT02184286
Pharmacokinetic Interaction Between Nevirapine and Saquinavir-sgc in HIV-1 Infected Patients
A Phase 1 study testing Nevirapine and Saquinavir-sgc in people with HIV Infections, run by Boehringer Ingelheim.
Trial summary
The objectives of this study are to determine the effects of nevirapine on the steady-state pharmacokinetics of saquinavir-sgc and to determine the effects of saquinavir-sgc on the steady-state pharmacokinetics of nevirapine. 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 and Saquinavir-sgc
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- No sites listed yet
- Study dates
- May 1999to Feb 2000
- 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 who are seropositive for HIV-1 antibody by an ELISA test and confirmed by an alternative method, e.g. Western blot
- Patients who meet the following laboratory parameters:
- Granulocyte count ≥ 1000 cells/mm3
- Hemoglobin ≥ 9.0 g(dL (men and women)
- Platelet count ≥ 75,000 cells/mm3
- Alkaline phosphatase ≤ 3.0 times the upper limit of normal
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- Serum glutamic oxalo-acetic 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
- Patients receiving a stable antiretroviral regimen, including saquinavir-sgc (Fortovase®) 1600 mg b.i.d. in the 28 days prior to visit 1
- Female patients of childbearing potential must be willing to use a reliable form of contraception, which should include a medically approved form of barrier contraception
- Patients able to provide written informed consent and comply with study requirements
- Patients with a viral load less than 400 copies/mL
Who cannot join
- Female patients who are pregnant or breastfeeding
- Patients requiring systemic treatment with corticosteroids or drugs known to be hepatic enzyme inducers or inhibitors in the 14 days prior to visit 1. Such substances in these categories include macrolide antibiotics (erythromycin, clarithromycin, azithromycin, dirithromycin), azole antifungals (ketoconazole, fluconazole, itraconazole), rifampin, rifabutin, and phenytoin
- Patients with previous exposure to (or are currently being treated with) non-nucleoside reverse transcriptase inhibitors (NNRTIs)
- Patients receiving a protease inhibitor other than saquinavir-sgc (Fortovase®) in the 28 days prior to visit 1
- Patients receiving any investigational drug, antineoplastic agent or radiotherapy other than local skin radiotherapy treatment in the 12 weeks prior to visit 1
- Patients with malabsorption, severe chronic diarrhea or patients unable to maintain adequate oral intake
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- Patients with a current history of intravenous drug abuse, alcohol or substance abuse (within the last year)
- Patients undergoing treatment for an active infection
- Patients who are heavy smokers (≥ 20 cigarettes or cigars per day)
About this study
Official title: An Investigation of the Potential Pharmacokinetic Interaction Between Nevirapine (VIRAMUNE®) and Saquinavir-sgc (Fortovase®) in HIV-1 Infected Patients
The objectives of this study are to determine the effects of nevirapine on the steady-state pharmacokinetics of saquinavir-sgc and to determine the effects of saquinavir-sgc on the steady-state pharmacokinetics of nevirapine. This study will also evaluate the pharmacokinetics of nevirapine in combination with saquinavir-sgc compared to historical controls treated with nevirapine but without saquinavir-sgc.
- Conditions
- HIV Infections
- Being tested
- Nevirapine, Saquinavir-sgc
- 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
200 mg q.d. days 1-14 followed by 200 mg b.i.d. days 15-28
Saquinavir-sgcDrug
1600 mg b.i.d. from pre trial to day 28
| Study group | Role | What they receive |
|---|---|---|
| Nevirapine + Saquinavir-sgc | Experimental | Not described Receives: Drug: Nevirapine; Drug: Saquinavir-sgc |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum observed concentration (Cmax)
Measured: up to 12 hours post-dose on days 1 and 28
Time of maximum concentration (Tmax)
Measured: up to 12 hours post-dose on days 1 and 28
Minimum observed concentration (Cmin)
Measured: up to 12 hours post-dose on days 1 and 28
Area under the plasma concentration time profile over the steady-state dosing interval (AUCτ)
Measured: up to 12 hours post-dose on days 1 and 28
Systemic clearance (Cl/F)
Measured: up to 12 hours post-dose on days 1 and 28
Secondary outcomes (3)
Change in HIV RNA levels
Measured: Baseline and day 28
Change in cluster differentiation 4 positive (CD4+) count
Measured: Baseline and day 28
Number of patients with adverse events
Measured: up to 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2014 (estimated)
- Study startMay 1999
- Primary completionFeb 2000
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 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
- NCT02184286
- Sponsor's protocol ID
- 1100.1280
- Status last verified
- Jul 2014
- First submitted
- 8 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 Saquinavir-sgc (Fortovase®) in HIV-1 Infected Patients
- ClinicalTrials.gov ID
- NCT02184286
- Acronym / sponsor ID
- 1100.1280
- Conditions
- HIV Infections
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- May 1999
- Primary completion
- Feb 2000 (actual)
- First posted
- 9 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 objectives of this study are to determine the effects of nevirapine on the steady-state pharmacokinetics of saquinavir-sgc and to determine the effects of saquinavir-sgc on the steady-state pharmacokinetics of nevirapine. This study will also evaluate the pharmacokinetics of nevirapine in combination with saquinavir-sgc compared to historical controls treated with nevirapine but without saquinavir-sgc.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nevirapine + Saquinavir-sgc | Experimental | Drug: Nevirapine, Drug: Saquinavir-sgc |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Male or female patients between the ages of 18 and 65 years who are seropositive for HIV-1 antibody by an ELISA test and confirmed by an alternative method, e.g. Western blot
- Patients who meet the following laboratory parameters:
- Patients receiving a stable antiretroviral regimen, including saquinavir-sgc (Fortovase®) 1600 mg b.i.d. in the 28 days prior to visit 1
- Female patients of childbearing potential must be willing to use a reliable form of contraception, which should include a medically approved form of barrier contraception
- Patients able to provide written informed consent and comply with study requirements
Key exclusion criteria (9 listed)
- Female patients who are pregnant or breastfeeding
- Patients requiring systemic treatment with corticosteroids or drugs known to be hepatic enzyme inducers or inhibitors in the 14 days prior to visit 1. Such substances in these categories include macrolide antibiotics (erythromycin, clarithromycin, azithromycin, dirithromycin), azole antifungals (ketoconazole, fluconazole, itraconazole), rifampin, rifabutin, and phenytoin
- Patients with previous exposure to (or are currently being treated with) non-nucleoside reverse transcriptase inhibitors (NNRTIs)
- Patients receiving a protease inhibitor other than saquinavir-sgc (Fortovase®) in the 28 days prior to visit 1
- Patients receiving any investigational drug, antineoplastic agent or radiotherapy other than local skin radiotherapy treatment in the 12 weeks prior to visit 1
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 |
|---|---|---|
| Nevirapine200 mg q.d. days 1-14 followed by 200 mg b.i.d. days 15-28 | Drug | Nevirapine + Saquinavir-sgc |
| Saquinavir-sgc1600 mg b.i.d. from pre trial to day 28 | Drug | Nevirapine + Saquinavir-sgc |
Primary outcome
Maximum observed concentration (Cmax)
Time frame: up to 12 hours post-dose on days 1 and 28
Time of maximum concentration (Tmax)
Time frame: up to 12 hours post-dose on days 1 and 28
Minimum observed concentration (Cmin)
Time frame: up to 12 hours post-dose on days 1 and 28
Area under the plasma concentration time profile over the steady-state dosing interval (AUCτ)
Time frame: up to 12 hours post-dose on days 1 and 28
Systemic clearance (Cl/F)
Time frame: up to 12 hours post-dose on days 1 and 28
3 secondary outcomes
Change in HIV RNA levels
Time frame: Baseline and day 28
Change in cluster differentiation 4 positive (CD4+) count
Time frame: Baseline and day 28
Number of patients with adverse events
Time frame: up to 28 days
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 and Saquinavir-sgc 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 12 inclusion and 9 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?
Maximum observed concentration (Cmax) (time frame: up to 12 hours post-dose on days 1 and 28). The study lists 5 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.