NCT02993237

Study to Assess the Acceptability/Swallowability of DRV-Containing FDC Tablets in HIV-1 Infected Adolescents, Using Matching Placebo Tablets

A Study to Assess the Acceptability/Swallowability of DRV-containing FDC Tablets in HIV-1 Infected Adolescents, Using Matching Placebo Tablets

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: Janssen Research & Development, LLC · Industry
• Sex: All
• Age: 12 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

The primary purpose of this study is to assess the acceptability of swallowing the darunavir/cobicistat (DRV/COBI) and darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) fixed-dose combination (FDC) tablets, using matching placebo tablets, in human immunodeficiency virus (HIV) -1 infected adolescent patients.

Conditions

• HIV-1

Interventions

Type	Name	Description
DRUG	DRV/COBI FDC placebo tablet	Participants will receive 1 placebo tablet matching the DRV/COBI 800/150 milligram (mg) FDC
DRUG	D/C/F/TAF FDC placebo tablets	Participants will receive 1 placebo tablet matching the D/C/F/TAF 800/150/200/10 mg FDC.

Timeline

• Start date: 2017-01-23
• Primary completion: 2017-05-25
• Completion: 2017-05-25
• First posted: 2016-12-15
• Last updated: 2019-05-13

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study