NCT02818348

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jun 2016

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2016

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

June 20, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 29, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 23, 2016

Completed
Last Updated

March 12, 2018

Status Verified

March 1, 2018

Enrollment Period

4 months

First QC Date

June 20, 2016

Last Update Submit

March 9, 2018

Conditions

HIV-1 Infection

Keywords

HIV infectionDarunavir/cobicistatEtravirine, drug-drug interactionsPopulation PK analysis

Outcome Measures

Primary Outcomes (5)

  • Darunavir, cobicistat and etravirine concentrations in plasma

    on day 7 (PK1)

  • Darunavir, cobicistat and etravirine concentrations in plasma

    on day 14 (PK2)

  • Darunavir, cobicistat and etravirine concentrations in plasma

    on day 21 (PK2)

  • Grade ≥3 adverse events and serious adverse events

    From baseline to 28 days follow-up (ETR cohort)

  • Grade ≥3 adverse events and serious adverse events

    From baseline to 35 days follow-up (DRV/c cohort)

Secondary Outcomes (3)

  • HIV-1 RNA load in plasma

    baseline

  • HIV-1 RNA load in plasma

    on day 28 (ETR cohort)

  • HIV-1 RNA load in plasma

    on day 35 (DRV/c cohort)

Study Arms (2)

DRV cohort

EXPERIMENTAL

Darunavir/Cobicistat 800/150 mg, once daily during 35 days + etravirine 400 mg, once daily during 14 days

Drug: darunavir/cobicistatDrug: etravirine

ETR cohort

EXPERIMENTAL

Etravirine 400 mg, once daily during 28 days + darunavir/cobicistat 800/150 mg, once daily during 7 days

Drug: darunavir/cobicistatDrug: etravirine

Interventions

darunavir/cobicistatDRUG

800/150 mg, once daily during 35 days + etravirine 400 mg, once daily during 14 days

Also known as: Rezolsta
DRV cohortETR cohort
etravirineDRUG

400 mg, once daily during 28 days + darunavir/cobicistat 800/150 mg, once daily during 7 days

Also known as: Intelence
DRV cohortETR cohort

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age ≥18 years old
  • Documented HIV infection (western blot)
  • Stable antiretroviral treatment including darunavir/cobicistat 800/150mg QD (cohort DRV) or etravirine 400mg QD (cohort ETR) for at least 4 weeks. Plasma HIV-1 RNA load \<50 copies/mL for at least 12 weeks
  • In women of childbearing age\*, commitment to use at least one of these birth control methods: male or female condom with or without spermicide, cap, diaphragm or sponge with or without spermicide, intrauterine device, bilateral tubal occlusion, vasectomised partner, sexual abstinence during the study.
  • Signed Informed Consent
  • According to recommendations of Clinical Trial Facilitation Group (CTFG), a woman is considered of childbearing potential: fertile, following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy.

You may not qualify if:

  • Inadequate adherence to antiretroviral treatment (\<90% during the last week)
  • Patients who are taking or have been taking any other medication within the last two weeks prior to be recruited in the study, including herbal medicines and food supplements, with known interactions with darunavir, cobicistat or etravirine (i.e St. John's wort, grapefruit juice, some antibiotics such as erythromycin or rifampicin; antiepileptics such as phenytoin, phenobarbital or carbamazepine; antifungals such as itraconazole or ketoconazole; antiretrovirals such as ritonavir, efavirenz or nevirapine, among others.)
  • Acute illness that could interfere with darunavir, cobicistat or etravirine pharmacokinetics (acute hepatitis…) within the prior 4 weeks
  • Active AIDS-defining illness within the prior 4 weeks
  • In women, pregnancy or breastfeeding.
  • Evidence or clinical suspicion that the patient will not be able to complete the study treatment and protocol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fundació Lluita contra la SIDA

Badalona, Barcelona, 08916, Spain

Location

MeSH Terms

Conditions

HIV Infections

Interventions

cobicistat mixture with darunaviretravirine

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 20, 2016

First Posted

June 29, 2016

Study Start

June 1, 2016

Primary Completion

October 1, 2016

Study Completion

November 23, 2016

Last Updated

March 12, 2018

Record last verified: 2018-03

Locations

ES(1)