NCT02818348 is a Phase 1 clinical trial of darunavir/cobicistat in HIV-1 Infection, sponsored by Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia.

What drugs are being tested in NCT02818348?

Interventions in NCT02818348: darunavir/cobicistat, etravirine.

What condition does NCT02818348 study?

NCT02818348 studies HIV-1 Infection.

Is NCT02818348 still recruiting?

NCT02818348 is currently completed. Last updated 9 March 2018.

Last reviewed 2018-03-09 · How we verify

NCT02818348

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Clinical Trial to Evaluate Drug-drug Interactions Between Darunavir/Cobicistat and Etravirine in Hiv- Infected Patients

Completed Phase 1 Last updated 9 March 2018

What this trial tests

Phase 1 trial testing darunavir/cobicistat in HIV-1 Infection in 30 participants. Completed in 23 November 2016.

Timeline

1 June 2016

Primary endpoint
1 October 2016

23 November 2016

Quick facts

Lead sponsor	Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	basic science
Enrollment	30
Start date	1 June 2016
Primary completion	1 October 2016
Estimated completion	23 November 2016
Sites	1 location across Spain

Drugs / interventions tested

darunavir/cobicistat — full drug profile →
etravirine (ETRAVIRINE) — full drug profile →

Conditions studied

HIV-1 Infection — all drugs for HIV-1 Infection →

Sponsor

Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia — full company profile →

Who can join

Adults 18 to 64, any sex, with HIV-1 Infection. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Darunavir, cobicistat and etravirine concentrations in plasma
Time frame: on day 7 (PK1)
Darunavir, cobicistat and etravirine concentrations in plasma
Time frame: on day 14 (PK2)
Darunavir, cobicistat and etravirine concentrations in plasma
Time frame: on day 21 (PK2)
Grade ≥3 adverse events and serious adverse events
Time frame: From baseline to 28 days follow-up (ETR cohort)
Grade ≥3 adverse events and serious adverse events
Time frame: From baseline to 35 days follow-up (DRV/c cohort)

Sponsor's own description

This study aims to provide information about the safety and pharmacokinetic drug-drug interactions between darunavir/cobicistat (800/150mg QD) and etravirine (400mg QD) in HIV-infected patients, as well as evaluate the efficacy of concomitant administration of darunavir/cobicistat and etravirine.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other trials of darunavir/cobicistat

Trials testing the same drug.

NCT00042289 — Pharmacokinetic Study of Antiretroviral Drugs and Related Drugs During and After Pregnancy · completed

Other recruiting trials for HIV-1 Infection

Currently open trials in the same condition.

NCT06660498 — Pomalidomide as an Immune-enhancing Agent for the Control of HIV · Phase 1, PHASE2 · recruiting
NCT06602622 — Change in Body Weight and BMI in PWH with DOR/3TC/TDF Compared with INSTI · Phase 4 · recruiting
NCT05705349 — DOR/ISL in HIV-1 Antiretroviral Treatment-naïve Participants (MK-8591A-053) · Phase 3 · active not recruiting
NCT05631093 — A Switch to Doravirine/Islatravir (DOR/ISL) in Participants With Human Immunodeficiency Virus Type 1 (HIV-1) Who Are Vir · Phase 3 · active not recruiting
NCT05630755 — A Switch to Doravirine/Islatravir (DOR/ISL) in Participants With Human Immunodeficiency Virus Type 1 (HIV-1) Who Are Vir · Phase 3 · active not recruiting

Other Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia trials

Trials by the same sponsor.

NCT07264686 — Ulcer Plants: Highly Accessible Plant Antiseptics for Use in Remote Areas of PNG - Second Trial · Phase 2 · active not recruiting
NCT07267390 — Investigating MPXV Viral Clearance in Mpox Cases and Secondary Attack Rate in Contacts · recruiting
NCT07197164 — Safety and Effectiveness of a Remdesivir Treatment to Prevent Severe COVID-19 in Kidney Transplant Patients · Phase 2 · recruiting
NCT06766825 — Study to Evaluate the Efficacy and Safety of Plitidepsin in Adults With Post-COVID-19 Condition (PCC) · Phase 2 · recruiting
NCT06690814 — Ulcer Plants: Highly Accessible Plant Antiseptics for Use in Remote Areas of PNG · Phase 2 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02818348 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
Last refreshed: 9 March 2018

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02818348.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing