Characteristics and Outcomes of Patients Who Received Etravirine and/or Darunavir
NCT04194021 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 871
Last updated 2023-04-18
Summary
The objectives of this data collection activity are to:
1. Describe the baseline demographics, clinical and laboratory profile of patients who ever received darunavir (DRV) and/or etravirine (ETR), at the time of initiation on DRV and/or ETR;
2. Describe the clinical and laboratory profile of patients who ever received DRV and/or ETR every 6 months from the first data collection point through 2021;
3. Describe dynamics in HIV drug resistance mutations among patients who fail treatment on new regimens including DRV and/or ETR;
4. Describe demographics, clinical and laboratory profile of young adults who transition out of the donation program after the age of 25 years at 12 months after their transition.
Conditions
Sponsors & Collaborators
-
Janssen, LP
collaborator INDUSTRY -
Elizabeth Glaser Pediatric AIDS Foundation
lead OTHER
Principal Investigators
-
Appolinaire Tiam, MBChB, MMed · Elizabeth Glaser Pediatric AIDS Foundation
Eligibility
- Max Age
- 25 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2019-01-01
- Primary Completion
- 2022-12-31
- Completion
- 2023-12-31
Countries
- Cameroon
- Eswatini
- Kenya
- Lesotho
- Uganda
Study Locations
More Related Trials
-
Etravirine Plus 2 Analogs in HIV-infected Patients
NCT01437241 ·Status: COMPLETED
-
A Phase 2B Multicenter, Randomized, Comparative Trial Of UK-453,061 Versus Etravirine In Combination With Darunavir/Ritonavir And A Nucleos(t)Ide Reverse Transcriptase Inhibitor For The Treatment Of Antiretroviral Experienced HIV-1 Infected Subjects With Evidence Of NNRTI Resistant HIV-1
NCT00823979 ·Status: TERMINATED ·Phase: PHASE2
-
Human Immunodeficiency Virus (HIV) Postexposure Prophylaxis (PEP) With Darunavir/Ritonavir (DRV/r)
NCT01516970 ·Status: COMPLETED ·Phase: PHASE3
-
Efficacy Study of Substitution of Darunavir/Ritonavir (DRV/r) for Dual-boosted Protease Inhibitors
NCT00543101 ·Status: COMPLETED ·Phase: PHASE4
-
A Study of the Once Daily Combination of Etravirine and Darunavir/Ritonavir As Dual Therapy in Early Treatment-Experienced Patients
NCT01199939 ·Status: COMPLETED ·Phase: PHASE2
-
Clinical Trial to Assess the Efficacy of Darunavir/Ritonavir (DRV/r), Etravirine (ETV) and Raltegravir (MK-0518) in HIV Patients With Resistant Viruses
NCT00460382 ·Status: COMPLETED ·Phase: PHASE2
-
Study in Healthy Males to Measure Darunavir and Etravirine in Blood, Seminal Fluid, and Rectal Tissue
NCT00855088 ·Status: COMPLETED ·Phase: PHASE1
-
DRV/r + RPV QD: Efficacy and Toxicity Reduction
NCT01792570 ·Status: COMPLETED ·Phase: PHASE3
-
Metabolic Effects of Atazanavir/Ritonavir Versus Darunavir/Ritonavir in Combination With Tenofovir/Emtricitabine in naïve HIV-1 Infected Patients
NCT01274780 ·Status: COMPLETED ·Phase: PHASE4
-
A Study to Evaluate Antiviral Activity of Darunavir + Ritonavir in HIV-1 Infected Adolescents
NCT00915655 ·Status: COMPLETED ·Phase: PHASE2
-
Post-marketing Safety Surveillance Program in Human Immunodeficiency Virus (HIV)-Infected Children Exposed to Atazanavir in Europe
NCT01389310 ·Status: COMPLETED
-
TMC114-TiDP29-C232 - Study Providing Continued Access to Treatment With Darunavir (DRV)/Ritonavir (Rtv) for Children Coming From Any of the Three Ongoing Tibotec Sponsored Pediatric Studies With DRV
NCT01138605 ·Status: COMPLETED ·Phase: PHASE2
-
TMC125-TiDP2-C238: An Exploratory Pharmacokinetics, Safety and Anti-HIV Activity Study of Etravirine (ETR) When Given With Boosted Atazanavir (ATV/Rtv) at Two Different Doses and 1 Nucleoside Reverse Transcriptase Inhibitor (NRTI) in Treatment Experienced HIV Patients
NCT00896051 ·Status: COMPLETED ·Phase: PHASE2
-
Study Evaluating the Efficacy of a Reduced Dose Atazanavir in HIV-1-infected Patients
NCT02473328 ·Status: COMPLETED ·Phase: PHASE2
-
A Prospective Double-Blind Study of Retrovir in Early HIV Infection
NCT00002045 ·Status: COMPLETED ·Phase: NA
-
A Clinical Trial Comparing the Efficacy of Darunavir/Ritonavir Monotherapy Versus a Triple Combination Therapy Containing Darunavir/Ritonavir and 2 Nucleoside/Nucleotide Reverse Transcriptase Inhibitors in Patients With Undetectable Plasma HIV-1 RNA on Current Treatment
NCT01448707 ·Status: COMPLETED ·Phase: PHASE3
-
A Study to Compare Brachial Artery Reactivity and Cardiovascular Risk of a Treatment Simplification by Darunavir/Ritonavir (DRV/r) 800/100 mg Versus a Triple Combination Therapy Containing DRV/r in HIV-1 Infected Patients
NCT01391013 ·Status: COMPLETED ·Phase: PHASE2
-
Drug-drug Interaction (DDI) Study of GSK3640254 With Darunavir/Ritonavir (DRV/RTV) and Etravirine (ETR)
NCT04630002 ·Status: COMPLETED ·Phase: PHASE1
-
Study to Evaluate Darunavir/Ritonavir + Lamivudine Versus Continuing With Darunavir/Ritonavir + Tenofovir/Emtricitabine or Abacavir/Lamivudine in HIV Infected Subject
NCT02159599 ·Status: COMPLETED ·Phase: PHASE4
-
Raltegravir And Darunavir Antiretroviral in Antiretroviral Naive Patients
NCT00677300 ·Status: COMPLETED ·Phase: PHASE4
-
A Study of Potential Drug-Drug Interaction Between Efavirenz and Danoprevir With Low Dose Ritonavir in Healthy Volunteers
NCT01588002 ·Status: COMPLETED ·Phase: PHASE1
-
Pharmacokinetics of Once Daily Darunavir/Ritonavir in HIV-infected Children
NCT02285478 ·Status: COMPLETED
-
Pharmacokinetics of Atazanavir in Special Populations
NCT03923231 ·Status: COMPLETED
-
A Retrospective Study to Evaluate the Safety and Efficacy of a Nucleoside-Sparing Regimen of Darunavir, Ritonavir, and Dolutegravir
NCT03198884 ·Status: COMPLETED
-
Strategy for Maintenance of HIV Suppression With Once Daily Integrate Inhibitor+Darunavir/Ritonavir in Children
NCT02383108 ·Status: COMPLETED ·Phase: PHASE2/PHASE3