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Digital Health Technology
Digital Health Feedback System for HIV/AIDS
Phase 4
Waitlist Available
Research Sponsored by University of California, San Diego
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 16 weeks
Awards & highlights
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial
Summary
This trialtests new sensors and a mobile device to track when HIV patients take their medications, and to send that info to healthcare providers.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 16 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~16 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Medication taking adherence
Secondary study objectives
Medication behavior during IS-ARV use
Participants will be classified into groups according to the accurate measurement of adherence
The persistence of sensor-enabled ingestions
Awards & Highlights
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
1Treatment groups
Experimental Treatment
Group I: DHFS with IS-ARVExperimental Treatment1 Intervention
Digital Health Feedback System (DHFS) with either IS- Odefsey®, IS- Genvoya®, IS-Biktarvy®, IS- Tivicay® and Truvada® or IS- Tivicay® and Descovy ® (IS-co-encapsulated with ingestion sensor) -1 or 2 capsules daily (QD), depending on the treatment regimen, administered orally for 16 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Digital Health Feedback System
2013
Completed Phase 4
~120
Find a Location
Who is running the clinical trial?
University of California, San DiegoLead Sponsor
1,180 Previous Clinical Trials
1,574,947 Total Patients Enrolled
National Institute of Mental Health (NIMH)NIH
2,918 Previous Clinical Trials
2,740,072 Total Patients Enrolled
Gilead SciencesIndustry Sponsor
1,134 Previous Clinical Trials
867,859 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are currently taking a combination of two medications called Tivicay and Descovy.You are taking the medication Genvoya®.You are taking a medication called Odefsey®.You are taking a combination of Tivicay and Truvada medications.You have had pancreatitis in the past.You are taking Biktarvy® medication.You have a known sensitivity or allergy to adhesive materials used on the skin.
Research Study Groups:
This trial has the following groups:- Group 1: DHFS with IS-ARV
Awards:
This trial has 3 awards, including:- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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