HIV-DDIPhase 1NCT02556268
Interaction With HIV Antiretroviral Agents
A Phase 1 study testing Riociguat (Adempas, BAY 63-2521), ATRIPLA and COMPLERA in people with HIV-DDI, run by Bayer at 2 sites in United States.
Trial summary
To investigate the pharmacokinetic drug-drug interaction potential of fixed dose antiretroviral therapies, i.e. ATRIPLA, COMPLERA, STRIBILD, TRIUMEQ, or any approved antiretroviral protease inhibitor in combination with (preferably) TRIUMEQ, on the exposure to riociguat in HIV patients on a stable dose of one of these… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- HIV-DDI
- What is being tested?
- Riociguat (Adempas, BAY 63-2521), ATRIPLA and COMPLERA
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesUnited States
- Study dates
- 23 Feb 2016to 7 Dec 2016
- 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 aged >=18 to <65 years with a confirmed diagnosis of HIV receiving a stable regimen of ATRIPLA, COMPLERA, STRIBILD, TRIUMEQ, or any approved antiretroviral protease inhibitor such as atazanavir, darunavir, indinavir, ritonavir, and saquinavir in combination with (preferably) TRIUMEQ consistent with the most recent prescribing information documents for at least 6 weeks before concomitant administration of a single oral dose of 0.5 mg riociguat
- No clinical evidence of pulmonary hypertension
- Written informed consent
Who cannot join
- Severe diseases for which it can be assumed that the pharmacokinetics or effects of the study drug will not be normal
- History of coronary artery disease
- Symptomatic postural hypotension (e.g. dizziness, lightheadedness)
- History of bronchial asthma or any other airway disease
- Renal impairment with creatinine clearance <15 mL/min
- Severe hepatic impairment (Child-Pugh class C)
- Systolic blood pressure below 100 mmHg
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Study site
Boston, Massachusetts, 02118
Study site
Orlando, Florida, 32803
About this study
Official title: Potential Pharmacokinetic Interaction of Human Immunodeficiency Virus (HIV) Antiretroviral Agents as Fixed-dose Combinations and Riociguat in HIV Patients
To investigate the pharmacokinetic drug-drug interaction potential of fixed dose antiretroviral therapies, i.e. ATRIPLA, COMPLERA, STRIBILD, TRIUMEQ, or any approved antiretroviral protease inhibitor in combination with (preferably) TRIUMEQ, on the exposure to riociguat in HIV patients on a stable dose of one of these therapies.
- To Assess the safety and tolerability of riociguat treatment in combination with these fixed-dose antiretroviral therapies.
- Conditions
- HIV-DDI
- Being tested
- Riociguat (Adempas, BAY 63-2521), ATRIPLA, COMPLERA, STRIBILD, TRIUMEQ
- Keywords
- Single-Dose, Open-Label, Non-Blinded, Non-Placebo-, Controlled, Stratified Design
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Riociguat (Adempas, BAY 63-2521)Drug
0.5 mg, Oral (fasted conditions), 1 single dose
ATRIPLADrug
600 mg efavirenz, 200 mg emtricitabine, and 300 mg tenofovir disoproxil fumarate, i.e. 1 tablet, once daily
COMPLERADrug
200 mg emtricitabine, 25 mg rilpivirine, and 300 mg tenofovir disoproxil fumarate, i.e. 1 tablet, once daily
STRIBILDDrug
150 mg elvitegravir, 150 mg cobicistat, 200 mg emtricitabine, and 300 mg tenofovir disoproxil fumarate, i.e. 1 tablet, once daily
TRIUMEQDrug
600 mg abacavir, 50 mg dolutegravir, and 300 mg lamivudine, i.e. 1 tablet, once daily
Antiretroviral protease inhibitorDrug
Any approved antiretroviral protease inhibitor such as atazanavir, darunavir, indinavir, ritonavir, and saquinavir ; consistent with the most recent prescribing information documents
| Study group | Role | What they receive |
|---|---|---|
| Riociguat and ATRIPLA | Experimental | Not described Receives: Drug: Riociguat (Adempas, BAY 63-2521); Drug: ATRIPLA |
| Riociguat and COMPLERA | Experimental | Not described Receives: Drug: Riociguat (Adempas, BAY 63-2521); Drug: COMPLERA |
| Riociguat and STRIBILD | Experimental | Not described Receives: Drug: Riociguat (Adempas, BAY 63-2521); Drug: STRIBILD |
| Riociguat and TRIUMEQ | Experimental | Not described Receives: Drug: Riociguat (Adempas, BAY 63-2521); Drug: TRIUMEQ |
| Riociguat and antiretroviral protease inhibitor with TRIUMEQ | Experimental | Not described Receives: Drug: Riociguat (Adempas, BAY 63-2521); Drug: Antiretroviral protease inhibitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC of riociguat
Measured: at pre-dose and 0.5, 1, 1.5, 2, 4, 6, 8 24 and 48 hours post-dose
Cmax of riociguat
Measured: at pre-dose and 0.5, 1, 1.5, 2, 4, 6, 8 24 and 48 hours post-dose
AUC of riociguat main metabolite M1 (BAY 60-4552)
Measured: at pre-dose and 0.5, 1, 1.5, 2, 4, 6, 8 24 and 48 hours post-dose
Cmax of riociguat main metabolite M1 (BAY 60-4552)
Measured: at pre-dose and 0.5, 1, 1.5, 2, 4, 6, 8 24 and 48 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2015 (estimated)
- Study start23 Feb 2016
- Primary completion7 Dec 2016
- Study completion7 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV-DDIStudies of the same condition, open and under way.
- More trials run by BayerThe 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02556268
- Sponsor's protocol ID
- 17957
- Status last verified
- Dec 2017
- First submitted
- 21 Sep 2015
- Last updated
- 6 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Potential Pharmacokinetic Interaction of Human Immunodeficiency Virus (HIV) Antiretroviral Agents as Fixed-dose Combinations and Riociguat in HIV Patients
- ClinicalTrials.gov ID
- NCT02556268
- Acronym / sponsor ID
- 17957
- Conditions
- HIV-DDI
- Keywords
- Single-Dose, Open-Label, Non-Blinded, Non-Placebo-, Controlled, Stratified Design
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 23 Feb 2016 (actual)
- Primary completion
- 7 Dec 2016 (actual)
- Study completion
- 7 Dec 2016 (actual)
- First posted
- 22 Sep 2015 (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 investigate the pharmacokinetic drug-drug interaction potential of fixed dose antiretroviral therapies, i.e. ATRIPLA, COMPLERA, STRIBILD, TRIUMEQ, or any approved antiretroviral protease inhibitor in combination with (preferably) TRIUMEQ, on the exposure to riociguat in HIV patients on a stable dose of one of these therapies.
- To Assess the safety and tolerability of riociguat treatment in combination with these fixed-dose antiretroviral therapies.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Riociguat and ATRIPLA | Experimental | Drug: Riociguat (Adempas, BAY 63-2521), Drug: ATRIPLA |
| Riociguat and COMPLERA | Experimental | Drug: Riociguat (Adempas, BAY 63-2521), Drug: COMPLERA |
| Riociguat and STRIBILD | Experimental | Drug: Riociguat (Adempas, BAY 63-2521), Drug: STRIBILD |
| Riociguat and TRIUMEQ | Experimental | Drug: Riociguat (Adempas, BAY 63-2521), Drug: TRIUMEQ |
| Riociguat and antiretroviral protease inhibitor with TRIUMEQ | Experimental | Drug: Riociguat (Adempas, BAY 63-2521), Drug: Antiretroviral protease inhibitor |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female patients aged >=18 to <65 years with a confirmed diagnosis of HIV receiving a stable regimen of ATRIPLA, COMPLERA, STRIBILD, TRIUMEQ, or any approved antiretroviral protease inhibitor such as atazanavir, darunavir, indinavir, ritonavir, and saquinavir in combination with (preferably) TRIUMEQ consistent with the most recent prescribing information documents for at least 6 weeks before concomitant administration of a single oral dose of 0.5 mg riociguat
- No clinical evidence of pulmonary hypertension
- Written informed consent
Key exclusion criteria (7 listed)
- Severe diseases for which it can be assumed that the pharmacokinetics or effects of the study drug will not be normal
- History of coronary artery disease
- Symptomatic postural hypotension (e.g. dizziness, lightheadedness)
- History of bronchial asthma or any other airway disease
- Renal impairment with creatinine clearance <15 mL/min
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 |
|---|---|---|
| Riociguat (Adempas, BAY 63-2521)0.5 mg, Oral (fasted conditions), 1 single dose | Drug | Riociguat and ATRIPLA, Riociguat and COMPLERA, Riociguat and STRIBILD, Riociguat and TRIUMEQ, Riociguat and antiretroviral protease inhibitor with TRIUMEQ |
| ATRIPLA600 mg efavirenz, 200 mg emtricitabine, and 300 mg tenofovir disoproxil fumarate, i.e. 1 tablet, once daily | Drug | Riociguat and ATRIPLA |
| COMPLERA200 mg emtricitabine, 25 mg rilpivirine, and 300 mg tenofovir disoproxil fumarate, i.e. 1 tablet, once daily | Drug | Riociguat and COMPLERA |
| STRIBILD150 mg elvitegravir, 150 mg cobicistat, 200 mg emtricitabine, and 300 mg tenofovir disoproxil fumarate, i.e. 1 tablet, once daily | Drug | Riociguat and STRIBILD |
| TRIUMEQ600 mg abacavir, 50 mg dolutegravir, and 300 mg lamivudine, i.e. 1 tablet, once daily | Drug | Riociguat and TRIUMEQ |
| Antiretroviral protease inhibitorAny approved antiretroviral protease inhibitor such as atazanavir, darunavir, indinavir, ritonavir, and saquinavir ; consistent with the most recent prescribing information documents | Drug | Riociguat and antiretroviral protease inhibitor with TRIUMEQ |
Primary outcome
AUC of riociguat
Time frame: at pre-dose and 0.5, 1, 1.5, 2, 4, 6, 8 24 and 48 hours post-dose
Cmax of riociguat
Time frame: at pre-dose and 0.5, 1, 1.5, 2, 4, 6, 8 24 and 48 hours post-dose
AUC of riociguat main metabolite M1 (BAY 60-4552)
Time frame: at pre-dose and 0.5, 1, 1.5, 2, 4, 6, 8 24 and 48 hours post-dose
Cmax of riociguat main metabolite M1 (BAY 60-4552)
Time frame: at pre-dose and 0.5, 1, 1.5, 2, 4, 6, 8 24 and 48 hours post-dose
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 6 Dec 2017.
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.
Bayer Study Director study director
Bayer
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Riociguat (Adempas, BAY 63-2521), ATRIPLA and COMPLERA in people with HIV-DDI, run by Bayer at 2 sites 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 3 inclusion and 7 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 6 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
What does the primary outcome measure?
AUC of riociguat (time frame: at pre-dose and 0.5, 1, 1.5, 2, 4, 6, 8 24 and 48 hours post-dose). 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 6 Dec 2017.