MedDataX Logo

Interaction With HIV Antiretroviral Agents

NCT ID: NCT02556268

Last Updated: 2017-12-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-23

Study Completion Date

2016-12-07

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Dual Boosted - Protease Inhibitor (PI) Pharmacokinetics (PK) Trial (Tipranavir / Ritonavir) in Highly Treatment-experienced HIV-1 Infected Patients

NCT00056641

HIV Infections
COMPLETED PHASE2

Dual Versus Triple Protease Inhibitor Combinations, Including Ritonavir, in HIV Infected People

NCT00028366

HIV Infections
COMPLETED NA

Effects of Tipranavir/Ritonavir on the Pharmacokinetic Characteristics of Triple Drug Nucleoside and Non-nucleoside Reverse Transcriptase Inhibitor Therapy in HIV-1-infected Subjects

NCT02251223

HIV Infections
COMPLETED PHASE1/PHASE2

Exploratory Study of Tipranavir and Ritonavir in Multiple Protease Inhibitor-experienced HIV Patients

NCT02238314

HIV Infections
COMPLETED PHASE2

Drug Interactions Among Anti-HIV Agents

NCT00001766

HIV Infection
COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

HIV-DDI

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Riociguat and ATRIPLA

Group Type EXPERIMENTAL

Riociguat (Adempas, BAY 63-2521)

Intervention Type DRUG

0.5 mg, Oral (fasted conditions), 1 single dose

ATRIPLA

Intervention Type DRUG

600 mg efavirenz, 200 mg emtricitabine, and 300 mg tenofovir disoproxil fumarate, i.e. 1 tablet, once daily

Riociguat and COMPLERA

Group Type EXPERIMENTAL

Riociguat (Adempas, BAY 63-2521)

Intervention Type DRUG

0.5 mg, Oral (fasted conditions), 1 single dose

COMPLERA

Intervention Type DRUG

200 mg emtricitabine, 25 mg rilpivirine, and 300 mg tenofovir disoproxil fumarate, i.e. 1 tablet, once daily

Riociguat and STRIBILD

Group Type EXPERIMENTAL

Riociguat (Adempas, BAY 63-2521)

Intervention Type DRUG

0.5 mg, Oral (fasted conditions), 1 single dose

STRIBILD

Intervention Type DRUG

150 mg elvitegravir, 150 mg cobicistat, 200 mg emtricitabine, and 300 mg tenofovir disoproxil fumarate, i.e. 1 tablet, once daily

Riociguat and TRIUMEQ

Group Type EXPERIMENTAL

Riociguat (Adempas, BAY 63-2521)

Intervention Type DRUG

0.5 mg, Oral (fasted conditions), 1 single dose

TRIUMEQ

Intervention Type DRUG

600 mg abacavir, 50 mg dolutegravir, and 300 mg lamivudine, i.e. 1 tablet, once daily

Riociguat and antiretroviral protease inhibitor with TRIUMEQ

Group Type EXPERIMENTAL

Riociguat (Adempas, BAY 63-2521)

Intervention Type DRUG

0.5 mg, Oral (fasted conditions), 1 single dose

Antiretroviral protease inhibitor

Intervention Type DRUG

Any approved antiretroviral protease inhibitor such as atazanavir, darunavir, indinavir, ritonavir, and saquinavir ; consistent with the most recent prescribing information documents

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Riociguat (Adempas, BAY 63-2521)

0.5 mg, Oral (fasted conditions), 1 single dose

Intervention Type DRUG

ATRIPLA

600 mg efavirenz, 200 mg emtricitabine, and 300 mg tenofovir disoproxil fumarate, i.e. 1 tablet, once daily

Intervention Type DRUG

COMPLERA

200 mg emtricitabine, 25 mg rilpivirine, and 300 mg tenofovir disoproxil fumarate, i.e. 1 tablet, once daily

Intervention Type DRUG

STRIBILD

150 mg elvitegravir, 150 mg cobicistat, 200 mg emtricitabine, and 300 mg tenofovir disoproxil fumarate, i.e. 1 tablet, once daily

Intervention Type DRUG

TRIUMEQ

600 mg abacavir, 50 mg dolutegravir, and 300 mg lamivudine, i.e. 1 tablet, once daily

Intervention Type DRUG

Antiretroviral protease inhibitor

Any approved antiretroviral protease inhibitor such as atazanavir, darunavir, indinavir, ritonavir, and saquinavir ; consistent with the most recent prescribing information documents

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Bayer

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Orlando, Florida, United States

Site Status

Boston, Massachusetts, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

17957

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Interaction Study to Assess the Pharmacokinetic Interaction of Oral Administration of Rifapentine on ATRIPLA™ in HIV Patients
NCT01690403 COMPLETED PHASE1
Pharmacokinetic Study in Healthy Adult Volunteers to Assess the Interactions Between Steady-State Tipranavir and Atazanavir in the Presence of Ritonavir
NCT02253836 COMPLETED PHASE1
A Phase IIIb Study Comparing Two Boosted Protease Inhibitor-based HAART Regimens in HIV-infected Patients Experiencing Their First Virologic Failure While Receiving an NNRTI-containing HAART Regimen
NCT00135395 COMPLETED PHASE3
Atazanavir (BMS-232632) in Combination With Ritonavir or Saquinavir, and Lopinavir/Ritonavir, Each With Tenofovir and a Nucleoside in Subjects With HIV
NCT00035932 COMPLETED PHASE3
A Study to Evaluate the Pharmacokinetics of Rilpivirine/Tenofovir/Emtricitabine After a Single-Oral Administration in Healthy Japanese Adult Male Participants
NCT02530060 COMPLETED PHASE4
Tipranavir/Ritonavir vs. Genotypically Defined Protease Inhibitor/Ritonavir in HIV Patients (RESIST-2)
NCT00144170 COMPLETED PHASE3
Raltegravir vs. Lopinavir/Ritonavir, Both in Combination With Truvada, in HIV+ Treatment Naive Individuals
NCT00632970 TERMINATED PHASE4
Phase I Pharmacokinetic and Tolerance Study of Ribavirin in Human Immunodeficiency Virus (HIV) - Infected Patients
NCT00000733 COMPLETED PHASE1
Measure of Pharmacokinetic Parameters and Adherence With MEMS in Naive HIV Infected Patients Treated With Reyataz Once Daily Combined With Norvir and Truvada
NCT00528060 COMPLETED PHASE2
Drug Interaction Study With Atazanavir Administered With and Without Ritonavir and a Cytochrome P450 Substrate Rosiglitazone
NCT00362726 COMPLETED PHASE1
Using Drug Levels and Drug Resistance Testing to Select Effective Anti-HIV Drug Combinations in Patients With Drug-resistant HIV
NCT00027339 COMPLETED PHASE2
Tipranavir/Ritonavir Low Dose Pharmacokinetics in Treatment Naive Patients
NCT00530920 COMPLETED PHASE2
TMC125-TiDP2-C238: An Exploratory Pharmacokinetics, Safety and Anti-HIV Activity Study of Etravirine (ETR) When Given With Boosted Atazanavir (ATV/Rtv) at Two Different Doses and 1 Nucleoside Reverse Transcriptase Inhibitor (NRTI) in Treatment Experienced HIV Patients
NCT00896051 COMPLETED PHASE2
Drug Interaction Study With Famotidine, Atazanavir, and Atazanavir/Ritonavir/Tenofovir
NCT00365339 COMPLETED PHASE1
Dose Ranging Trial of Tipranavir/Ritonavir in Treatment-Experienced HIV Infected Individuals
NCT00034866 COMPLETED PHASE2
Pharmacokinetics of Atazanavir/Ritonavir in HIV-1 Infected Pregnant Women
NCT00326716 COMPLETED PHASE1
Effects of Famotidine on the Pharmacokinetics of Atazanavir When Coadministered to Participants With HIV Infection
NCT01232127 COMPLETED PHASE4
Study of Lopinavir, Ritonavir, Tenofovir and Emtricitabine in HIV-Infected Antiretroviral Naïve Subjects
NCT00043966 COMPLETED PHASE3
Drug Interaction Study Between GSK1349572 and Tipranavir/Ritonavir in Healthy Volunteers
NCT01068925 COMPLETED PHASE1
Tipranavir and Ritonavir vs. Saquinavir and Ritonavir Used With Two Nucleoside Reverse Transcriptase Inhibitors in Single Protease Inhibitor-experienced HIV-1 Patients
NCT02239835 TERMINATED PHASE2
Randomized Evaluation of Strategic Intervention in Multidrug Resistant Patients With Tipranavir (RESIST)
NCT00054717 COMPLETED PHASE3
TMC114-C202: A Study of Safety, Efficacy, and Tolerability of TMC114 and Low Dose Ritonavir in HIV-1 Infected Patients
NCT00071097 COMPLETED PHASE2
The Interaction of Two HIV Medications With Blood Clot Medications in Healthy Volunteers
NCT01896622 COMPLETED PHASE1
Second-line Treatment of HIV-1 With Ritonavir Boosted Atazanavir or Darunavir With an Optimized NRTI Backbone
NCT01605084 WITHDRAWN PHASE3
Pharmacokinetics of Tenofovir and Tenofovir-diphosphate, Emtricitabine and Emtricitabine-triphosphate, and Rilpivirine Once Daily Over 14 Days Following Drug Intake Cessation in Healthy Volunteers
NCT01796431 COMPLETED PHASE1