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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

NCT05197075 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2023-09-14

No results posted yet for this study

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.

Conditions

  • Human Immunodeficiency Virus (HIV)

Interventions

DRUG

DRV/COBI FDC

DRV/COBI FDC tablet dispersed in water will be administered orally.

Sponsors & Collaborators

  • Janssen Research & Development, LLC

    lead INDUSTRY

Principal Investigators

  • Janssen Research and Development, LLC Clinical Trial · Janssen Research and Development LLC

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
3 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-03
Primary Completion
2022-09-23
Completion
2022-09-23
FDA Drug
Yes

Countries

  • United States
  • South Africa
  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05197075 on ClinicalTrials.gov