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OpenTrials
Completed

NCT Number: NCT02556268

Interaction With HIV Antiretroviral Agents

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.

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Key information

Conditions

HIV-DDI

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Orlando, Florida, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Riociguat (Adempas, BAY 63-2521)

Drug

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

ATRIPLA

Drug

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

COMPLERA

Drug

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

Stribild

Drug

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

TRIUMEQ

Drug

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

Antiretroviral protease inhibitor

Drug

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

Primary outcomes

  1. AUC of riociguat

    Time frame: at pre-dose and 0.5, 1, 1.5, 2, 4, 6, 8 24 and 48 hours post-dose

  2. Cmax of riociguat

    Time frame: at pre-dose and 0.5, 1, 1.5, 2, 4, 6, 8 24 and 48 hours post-dose

  3. 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

  4. 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

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

Potential Pharmacokinetic Interaction of Human Immunodeficiency Virus (HIV) Antiretroviral Agents as Fixed-dose Combinations and Riociguat in HIV Patients

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Sep 22, 2015
Registry last updated
Dec 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.