Clinical Trials Logo
  1. Home
  2. Other
  3. NCT05197075

A Study to Assess the Acceptability of the Darunavir/Cobicistat (DRV/COBI) Fixed-dose Combination (FDC) Tablet in Human Immunodeficiency Virus (HIV)-1 Infected Children

Human Immunodeficiency Virus (HIV) Clinical Trial

Official title:
A Study to Assess the Acceptability of the Darunavir/Cobicistat (DRV/COBI) Fixed-dose Combination (FDC) Tablet in Human Immunodeficiency Virus (HIV)-1 Infected Children Aged >=3 Years and Weighing >=15 kg to <25 kg

Clinical Trial Summary

The purpose of the study is to assess the ability to swallow the Darunavir/Cobicistat (DRV/COBI) fixed dosed combination (FDC) tablet dispersed in water.

Clinical Trial Description

Human immunodeficiency virus type 1 (HIV-1) infection is a life-threatening and serious disease that is of major public health interest around the world. Standard-of-care for the treatment of HIV infection involves the use of a combination of antiretroviral (ARV) drugs to suppress viral replication to below detectable limits, to increase CD4+ cell count, and to delay disease progression. Darunavir (DRV) is an inhibitor of the dimerization and of the catalytic activity of the HIV-1 protease. It selectively inhibits the cleavage of HIV encoded Gag-Pol polyproteins in virus infected cells, thereby preventing the formation of mature infectious virus particles. Cobicistat (COBI) is a mechanism-based inhibitor (MBI) of the cytochrome P450 (CYP)3A subfamily. Inhibition of CYP3A mediated metabolism by COBI enhances the systemic exposure of CYP3A substrates, such as DRV, where bioavailability is limited and half-life is shortened by CYP3A-dependent metabolism. DRV/COBI FDC tablet formulation would overcome the difficulties of pediatric participants (greater than or equal to [>=] 3 years and weighing >=15 kilograms [kg] to less than [<] 25 kg) might encounter in swallowing a whole or 2 halves of an oral, non-disintegrating tablet, hence helping children to better adhere to their HIV treatment. The study consists of a screening phase (up to 21 days) and an open-label administration phase of 1 day. Safety will be assessed by adverse events (AEs). The total duration of the study is up to 32 days. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05197075
Study type Interventional
Source Janssen Research & Development, LLC
Contact
Status Completed
Phase Phase 1
Start date August 3, 2022
Completion date September 23, 2022
View Details
See also
  Status Clinical Trial Phase
Not yet recruiting NCT02511496 - Status of Chronic Liver Disease in Hepatitis C Virus (HCV) Patients Coinfected With Human Immunodeficiency Virus (HIV) in Andalusia N/A
Completed NCT02234492 - The Effects of Statin Therapy on Coronary Flow Reserve and Inflammatory Markers in HIV-Positive Patients Phase 4
Completed NCT02027441 - Enhanced Prevention in Couples: Feasibility Study #2 N/A
Completed NCT01685372 - Immunogenicity of Fluzone High Dose in Immunocompromised Children and Young Adults Phase 2
Completed NCT02165202 - Phase II Safety and Acceptability of an Investigational Injectable Product, TMC278LA, for Pre-Exposure Prophylaxis Phase 2
Completed NCT02572401 - Steering Together in a New Direction: Reducing the Risk of HIV/STD Among African American Men N/A
Terminated NCT01448486 - A Study of the Neurological Effects of Adding Raltegravir to HAART Regimen in Patients With HIV Phase 4
Completed NCT01449006 - A Study of the Neurological Effects of Adding Maraviroc to HAART Regimen in Patients With HIV (HANDmac) Phase 4
Completed NCT01615601 - An Observational Study to Evaluate Tolerability of PREZISTA or INTELENCE in HIV-1 Infected Patients Phase 4
Completed NCT04122404 - POC Strategies to Improve TB Care in Advanced HIV Disease N/A
Completed NCT03290755 - Sexual Hepatitis C in HIV Positive Men Who Have Sex With Men (MSM) in Bordeaux
Completed NCT02974998 - Cape Town Young Women's Health CoOp N/A
Completed NCT01516970 - Human Immunodeficiency Virus (HIV) Postexposure Prophylaxis (PEP) With Darunavir/Ritonavir (DRV/r) Phase 3
Completed NCT01997346 - Multi-level Determinants of Starting ART Late: Aim 2 N/A
Active, not recruiting NCT01875952 - Diagnosis and Treatment of Co-infection With Human Immunodeficiency Virus /Latent Tuberculosis Infection (HIV/TBL) Phase 4
Completed NCT01199939 - A Study of the Once Daily Combination of Etravirine and Darunavir/Ritonavir As Dual Therapy in Early Treatment-Experienced Patients Phase 2
Completed NCT03783130 - Dose, Safety, Tolerability, and Immunogenicity of an HIV-1 Vaccine, VRC-HIVRGP096-00-VP, With Alum in Healthy Adults Phase 1
Active, not recruiting NCT05657106 - Kentucky Outreach Service Kiosk (KyOSK): Reducing HIV, HCV, and Overdose Risk N/A
Not yet recruiting NCT05727033 - Extraordinarily Fun Training Project in Compulsory Secondary Education - Sexually Transmitted Infections N/A
Completed NCT01053741 - Effect of Seminal Fluid on the Colon Wall; Implications for HIV Transmission N/A