Human Immunodeficiency Virus (HIV) Clinical Trial
Official title:
A Multicenter, Single Arm, Open-Label Study of the Once Daily Combination of Etravirine and Darunavir/Ritonavir As Dual Therapy in Early Treatment-Experienced Patients
This study is a Phase II single arm, open-label, multicenter, study of 50 human immunodeficiency virus-1 (HIV) infected adult patients, all of whom will receive etravirine (ETR) 400mg and DRV/r 800/100mg each given orally once daily. This trial is designed to evaluate the efficacy of the aforementioned ARV regimen, as measured by the percentage of patients with HIV RNA <50 copies/mL at 48 weeks, in early treatment-experienced HIV-infected patients. In addition to general safety parameter measurements, this trial will also assess changes in metabolic, inflammatory, immune restoration, and bone markers. Screening will occur over a 6-week period. The primary endpoint will be assessed at Week 48, and the treatment period is 48 weeks. The end of study endpoint will be met by either completing the Week 48 visit, or by early termination from the study for any reason.
This study is a Phase II single arm, open-label, multicenter, (all people involved know the identity of the intervention) study of 50 HIV-1 infected adult patients, all of whom will receive ETR 400mg and darunavir (DRV)/r 800/100mg each given orally once daily. This trial is designed to evaluate the efficacy of the aforementioned ARV regimen, as measured by the percentage of patients with HIV ribonucleic acid (RNA) <50 copies/mL at 48 weeks, in early treatment-experienced HIV-infected patients. In addition to general safety parameter measurements, this trial will also assess changes in metabolic, inflammatory, immune restoration, and bone markers. Screening will occur over a 6-week period. The trial schedule includes a Baseline Visit (Day 1), Open-label Treatment Phase (Weeks 4, 8, 12, 16, 20, 24, 30, 36, 42, 48/ Early Withdrawal) and a Post-treatment Phase (4 Week Follow-Up) visit. In addition, all patients will have two pharmacokinetic (PK) samples drawn at Weeks 4 and 24, A single PK sample will be drawn at Weeks 12, 36, and 48 (or early withdrawal visit). There will also be a substudy conducting 24 hour intensive PK at week 4 for a subset of patients. For patients who consent, genotyping for CYP2C9 and CYP2C19 will be performed at Baseline. A Modified Medication Adherence Self-Report Inventory (M-MASRI) questionnaire will be collected, which is a patient-reported survey to assess adherence to medication taking. The primary endpoint will be assessed at Week 48, and the treatment period is 48 weeks. The end of study endpoint will be met by either completing the Week 48 visit, or by early termination from the study for any reason. ETR 400mg once daily for 48 weeks and DRV 800mg once daily for 48 weeks. ;
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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 |
NCT01615601 -
An Observational Study to Evaluate Tolerability of PREZISTA or INTELENCE in HIV-1 Infected Patients
|
Phase 4 | |
Completed |
NCT01449006 -
A Study of the Neurological Effects of Adding Maraviroc to HAART Regimen in Patients With HIV (HANDmac)
|
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 |
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 | |
Completed |
NCT02946047 -
The Effect of Ixazomib on the Latent HIV Reservoir
|
Phase 1/Phase 2 |