← Back to Search

Protease Inhibitor

HIV Medications for Children With HIV

Q: Are there any other existing research articles on DRV?

Presently, there are 17 clinical studies underway that are investigating DRV. Out of those 17 active trials, 8 are in Phase 3. Many of the trials for DRV are based in Chennai and Johannesburg, but there are a total of 229 locations running trials for this treatment globally.

Q: Are we recruiting participants for this research right now?

The latest information on clinicaltrials.gov indicates that this study is still actively recruiting patients. The trial was posted on 1/16/2014 and was most recently edited on 8/18/2022.

Q: Could you tell me if anyone below the age of 30 can sign up for this research program?

Presently, the study is looking for 3-17 year olds.

Q: Could I participate in this trial, assuming I meet the requirements?

This study is looking for 100 <a href="https://www.withpower.com/clinical-trials/hiv">HIV</a>-positive patients that meet the following requirements: Aged 3-17, treatment-experienced, virologically suppressed, males and females that weigh at least 25 kg, have been taking a stable antiretroviral regimen for at least 3 months that includes 2 nucleoside reverse transcriptase inhibitors and either ritonavir-boosted atazanavir or ritonavir-boosted darunavir once or twice daily, no history of DRV resistance associated mutations, and have negative screening for active pulmonary tuberculosis.

Q: What are the conditions that DRV is indicated for?

DRV is an approved treatment for patients with <a href="https://www.withpower.com/clinical-trials/hiv">hiv</a>, antiretroviral therapy, and a body weight of at least 35 kg.

Phase 2 & 3

Recruiting

Research Sponsored by Gilead Sciences

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

HIV-1 infected, virologically suppressed males and females Age ≥ 4 weeks to < 18 years

Participants enrolled prior to implementation of Amendment 7: 2 NRTIs and ATV/r once daily or DRV/r once daily or twice daily

Timeline

Screening 3 weeks

Treatment Varies

Follow Up first dose date up to week 48 plus 30 days (cumulative data through week 48)

Awards & highlights

Study Summary

This trial will investigate the safety and pharmacokinetics of two HIV medications, Atazanavir and Darunavir, in children and adolescents.

Who is the study for?

This trial is for children aged ≥4 weeks to <18 years with HIV who weigh between ≥3 kg and <40 kg, depending on the cohort. They must have stable antiretroviral regimens for at least 3 months, adequate kidney function, and no resistance to study drugs. Children under 14 kg with certain mutations are allowed if their viral load is low.Check my eligibility

What is being tested?

The study tests the safety and dosing of cobicistat-boosted Atazanavir (ATV/co), cobicistat-boosted Darunavir (DRV/co), and Emtricitabine/Tenofovir Alafenamide (F/TAF) in kids with HIV. It involves switching participants from their current treatments to these new drug combinations.See study design

What are the potential side effects?

Possible side effects may include digestive issues, liver problems, allergic reactions, changes in body fat distribution or bone density due to long-term use of HIV medications. Specific side effects related to each drug will be monitored closely.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am under 18, HIV positive, and my viral load is low.

Select...

I was treated with specific HIV medications before a certain study change.

Select...

My kidneys are functioning well, with an eGFR of 90 or higher.

Select...

I have no resistance to the study drugs FTC, TFV, ATV, DRV, or LPV.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ first dose date up to week 48 plus 30 days (cumulative data through week 48)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~first dose date up to week 48 plus 30 days (cumulative data through week 48)

This trial's timeline: 3 weeks for screening, Varies for treatment, and first dose date up to week 48 plus 30 days (cumulative data through week 48) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Percentage of Participants Experiencing Treatment Emergent Adverse Events (AEs) Through Week 24

Percentage of Participants Experiencing Treatment Emergent Laboratory Abnormalities Through Week 24

Pharmacokinetic (PK) Parameter: AUCtau of ATV, DRV, TAF, and TFV

Secondary outcome measures

Acceptability of COBI and F/TAF as Measured by Palatability Score

Change from Baseline in CD4+ Cell Counts (cells/μL) at Week 24

Change from Baseline in CD4+ Cell Counts (cells/μL) at Week 48

+13 more

Trial Design

10Treatment groups

Experimental Treatment

Group I: Cohort 5 (Group 3)Experimental Treatment2 Interventions

Participants ages ≥ 4 weeks old weighing ≥ 3 to < 6 kg will receive F/TAF TOS 15/1.88 mg, once daily with the third unboosted drug.

Group II: Cohort 5 (Group 2)Experimental Treatment2 Interventions

Participants ages ≥ 4 weeks old weighing ≥ 6 to < 10 kg will receive F/TAF TOS 30/3.75 mg, once daily with the third unboosted drug.

Group III: Cohort 5 (Group 1)Experimental Treatment2 Interventions

Participants ages ≥ 4 weeks old weighing ≥ 10 to < 14 kg will receive F/TAF TOS 60/7.5 mg, once daily with the third unboosted drug.

Group IV: Cohort 4 (Group 4)Experimental Treatment4 Interventions

Participants age ≥ 4 weeks old weighing 3 to < 6 kg will receive cobicistat TOS 30 mg (twice daily) and F/TAF TOS 15/1.88 mg, once daily with either ATV or LPV/r. Minimum age and weight for ATV is ≥ 3 months and ≥ 5 kg, respectively; participants receiving LPV/r will not receive cobicistat TOS.

Group V: Cohort 4 (Group 3)Experimental Treatment4 Interventions

Participants age ≥ 4 weeks old weighing 6 to < 10 kg will receive cobicistat TOS 30 mg (twice daily) and F/TAF TOS 30/3.75 mg, once daily with either ATV or LPV/r. Minimum age and weight for ATV is ≥ 3 months and ≥ 5 kg, respectively; participants receiving LPV/r will not receive cobicistat TOS.

Group VI: Cohort 4 (Group 2)Experimental Treatment4 Interventions

Participants age ≥ 4 weeks old weighing 10 to < 14 kg will receive cobicistat TOS 30 mg (twice daily) and F/TAF TOS 60/7.5 mg, once daily with either ATV or LPV/r. Minimum age and weight for ATV is ≥ 3 months and ≥ 5 kg, respectively; participants receiving LPV/r will not receive cobicistat TOS.

Group VII: Cohort 4 (Group 1)Experimental Treatment5 Interventions

Participants age ≥ 4 weeks old weighing 14 to < 25 kg will receive cobicistat tablet for oral suspension (TOS) 90 mg, once daily and F/TAF TOS 120/15 mg, once daily with either ATV or DRV or lopinavir boosted by ritonavir (LPV/r). Minimum age and weight for ATV is ≥ 3 months and ≥ 5 kg, minimum age and weight for DRV is ≥ 3 years and ≥ 15 kg; participants receiving LPV/r will not receive cobicistat TOS.

Group VIII: Cohort 3Experimental Treatment4 Interventions

Participants age ≥ 2 years old will receive cobicistat 90 mg and F/TAF 120/15 mg with either ATV or DRV.

Group IX: Cohort 2Experimental Treatment4 Interventions

Participants aged 6 to <12 years old and ≥25 to <40kg will receive cobicistat 150 mg and F/TAF 200/25 mg with either ATV or DRV.

Group X: Cohort 1: Part A and Part BExperimental Treatment4 Interventions

Participants ages 12 to <18 years old will receive cobicistat 150 mg with either ATV or DRV plus background regimen (BR). The BR may contain additional antiretroviral agents except for the following disallowed agents: saquinavir, indinavir, nelfinavir, double protease inhibitor (PI) regimens, raltegravir, elvitegravir, efavirenz, nevirapine, delavirdine, maraviroc, etravirine, rilpivirine, dolutegravir, and investigational antiretroviral agents.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

ATV

2016

Completed Phase 4

~6110

DRV

2015

Completed Phase 3

~1400

Cobicistat

2014

Completed Phase 2

~640

F/TAF

2019

Completed Phase 3

~2770

LPV/r

2010

Completed Phase 4

~400

2009

Completed Phase 1

~40

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Gilead SciencesLead Sponsor

1,084 Previous Clinical Trials

848,349 Total Patients Enrolled

Gilead Study DirectorStudy DirectorGilead Sciences

343 Previous Clinical Trials

186,563 Total Patients Enrolled

Media Library

Atazanavir (Protease Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT02016924 — Phase 2 & 3

Human Immunodeficiency Virus Infection Research Study Groups: Cohort 2, Cohort 5 (Group 2), Cohort 5 (Group 3), Cohort 4 (Group 1), Cohort 1: Part A and Part B, Cohort 3, Cohort 4 (Group 2), Cohort 4 (Group 3), Cohort 4 (Group 4), Cohort 5 (Group 1)

Human Immunodeficiency Virus Infection Clinical Trial 2023: Atazanavir Highlights & Side Effects. Trial Name: NCT02016924 — Phase 2 & 3

Atazanavir (Protease Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02016924 — Phase 2 & 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any other existing research articles on DRV?

"Presently, there are 17 clinical studies underway that are investigating DRV. Out of those 17 active trials, 8 are in Phase 3. Many of the trials for DRV are based in Chennai and Johannesburg, but there are a total of 229 locations running trials for this treatment globally."

Answered by AI

Are we recruiting participants for this research right now?

"The latest information on clinicaltrials.gov indicates that this study is still actively recruiting patients. The trial was posted on 1/16/2014 and was most recently edited on 8/18/2022."

Answered by AI

Could you tell me if anyone below the age of 30 can sign up for this research program?

"Presently, the study is looking for 3-17 year olds."

Answered by AI

Could I participate in this trial, assuming I meet the requirements?

"This study is looking for 100 HIV-positive patients that meet the following requirements: Aged 3-17, treatment-experienced, virologically suppressed, males and females that weigh at least 25 kg, have been taking a stable antiretroviral regimen for at least 3 months that includes 2 nucleoside reverse transcriptase inhibitors and either ritonavir-boosted atazanavir or ritonavir-boosted darunavir once or twice daily, no history of DRV resistance associated mutations, and have negative screening for active pulmonary tuberculosis."

Answered by AI