Effect on HIV Medications on EPC Cells
NCT03782142 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 22
Last updated 2022-03-22
Summary
This is a 3 arm, non-Interventional pilot single time point cross sectional study for the duration of 1 year. Total of 30 candidates (10 in each Group) will be enrolled into three different groups taking three different Antiretroviral regimen.
Based on current regimens that are commonly used (2017-2018 ART guidelines), our groups will include NRTI such as TAF (tenofovir alafenamide) or TDF(tenofovir disoproxil fumarate) plus one of the following:
Group A: an NNRTI (Non-nucleoside reverse transcriptase inhibitor, Rilpivirine Group B a boosted Protease Inhibitor: Prezcobix- \[darunavir+cobicistat combination\] Group C: an Integrase inhibitor (dolutegravir)
Once Informed Consent Process is obtained, blood will be drawn (55 ml) for stem/progenitor cell harvest and 15-20mls for biochemistry analysis. The Investigators will also obtain weight, waist-circumference, BP, pulse, BMI, Tanita body composition scale measures (which gives us body habitus measurements) and arterial stiffness measures.
Conditions
- AIDS
Interventions
- DRUG
-
Tenofovir
TAF (tenofovir alafenamide) or TDF(tenofovir disoproxil fumarate)
- DRUG
-
Rilpivirine
NNRTI
- DRUG
-
Prezcobix
PI
- DRUG
-
Dolutegravir
II
Sponsors & Collaborators
-
Sabyasachi Sen
lead OTHER
Eligibility
- Min Age
- 40 Years
- Max Age
- 70 Years
- Sex
- MALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-11-01
- Primary Completion
- 2020-11-12
- Completion
- 2021-12-14
- FDA Drug
- Yes
Countries
- United States
Study Locations
More Related Trials
-
Study to Evaluate Efficacy and Safety of Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (D/C/F/TAF) Regimen Versus Boosted Protease Inhibitor (bPI) Along With Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) Regimen in Virologically-Suppressed, HIV-1 Infected Participants
NCT02269917 ·Status: COMPLETED ·Phase: PHASE3
-
A Study to Evaluate Efficacy and Safety of Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (D/C/F/TAF) Fixed Dose Combination (FDC) Versus a Regimen Consisting of Darunavir/Cobicistat FDC With Emtricitabine/Tenofovir Disoproxil Fumarate FDC in Treatment-naive HIV Type 1 Infected Subjects
NCT02431247 ·Status: COMPLETED ·Phase: PHASE3
-
D/C/F/TAF Versus COBI-boosted DRV Plus FTC/TDF in HIV-1 Infected, Antiretroviral Treatment Naive Adults
NCT01565850 ·Status: COMPLETED ·Phase: PHASE2
-
Single Tablet Regimen (STR) Simplification Study for HIV-1 Infected Patients
NCT00365612 ·Status: COMPLETED ·Phase: PHASE4
-
Early Fast-Track Versus Standard Care for Persons With HIV Initiating TLD
NCT04311944 ·Status: UNKNOWN ·Phase: NA
-
Study of Tenofovir Disoproxil Fumarate (TDF) for Prevention of HIV
NCT00122512 ·Status: TERMINATED ·Phase: PHASE2
-
TMC125-TiDP35-C239 - Continued Access to Etravirine (ETR) in Treatment Experienced HIV-1 Infected Participants
NCT00980538 ·Status: COMPLETED ·Phase: PHASE3
-
Study to Evaluate Switching From Regimens Consisting of a Ritonavir-boosted Protease Inhibitor Plus Emtricitabine/Tenofovir Fixed-Dose Combination to the Elvitegravir/Cobicistat/Emtricitabine/Tenofovir DF Single-Tablet Regimen in Virologically Suppressed, HIV-1 Infected Patients
NCT01475838 ·Status: COMPLETED ·Phase: PHASE3
-
Efficacy of Tenofovir Alafenamide Versus Placebo Added to a Failing Regimen Followed by Treatment With Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide Plus Atazanavir in HIV-1 Positive, Antiretroviral Treatment-Experienced Adults
NCT01967940 ·Status: COMPLETED ·Phase: PHASE3
-
Study to Evaluate Switching From a Regimen Consisting of the Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate Single-Tablet Regimen (STR) to the Emtricitabine/Rilpivirine/Tenofovir Disoproxil Fumarate STR
NCT01286740 ·Status: COMPLETED ·Phase: PHASE2
-
Comparing Immune Activation and Latent HIV Reservoir Size Between People Living With HIV on Tenofovir-containing Versus NRTI-free ART
NCT05584397 ·Status: ENROLLING_BY_INVITATION
-
A Study to Evaluate the Efficacy and Safety of (D/C/F/TAF) Once Daily Fixed Dose Combination (FDC) Regimen in Newly Diagnosed, Antiretroviral Treatment-naive Human Immunodeficiency Virus Type 1 (HIV-1) Infected Participants Receiving Care in a Test and Treat Model of Care
NCT03227861 ·Status: COMPLETED ·Phase: PHASE3
-
A Clinical Trial Comparing the Efficacy of Tenofovir Disoproxil Fumarate/Emtricitabine/Rilpivirine (TDF/FTC/RPV) Versus TDF/FTC/Efavirenz (TDF/FTC/EFV) in Patients With Undetectable Plasma HIV-1 RNA on Current First-line Treatment
NCT01709084 ·Status: COMPLETED ·Phase: PHASE3
-
Open-Label Pilot Study to Evaluate Switching From a Regimen Consisting of Raltegravir Plus Emtricitabine/Tenofovir DF Fixed-Dose Combination to the Elvitegravir/Cobicistat/Emtricitabine/Tenofovir DF Single-Tablet Regimen in Virologically Suppressed, HIV-1 Infected Patients
NCT01533259 ·Status: COMPLETED ·Phase: PHASE3
-
Study to Evaluate Switching From Regimens Consisting of a Ritonavir-boosted Protease Inhibitor (PI) and Two Nucleoside Reverse Transcriptase Inhibitors (NRTIs) to a Fixed-dose Tablet Containing Emtricitabine/Rilpivirine/Tenofovir DF
NCT01252940 ·Status: COMPLETED ·Phase: PHASE3
-
A Study to Evaluate the Efficacy, Safety, Participant Choice and Preference of an Oral Once-daily Regimen or a Long-acting Injectable Regimen Every Two Months for Treatment of Human Immunodeficiency Virus (HIV-1) in Adults Who Have Not Previously Taken Antiretroviral Therapy
NCT05917509 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE3
-
Safety and Efficacy of Cobicistat-boosted Darunavir in HIV Infected Adults
NCT01440569 ·Status: COMPLETED ·Phase: PHASE3
-
Safety and Effectiveness of PEG-Intron in HIV-Infected Patients
NCT00005012 ·Status: COMPLETED ·Phase: PHASE2
-
Study to Evaluate Switching to Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (E/C/F/TAF) Fixed Dose Combination (FDC) in Virologically-Suppressed HIV-1 Infected Adults Harboring the Archived Isolated NRTI Resistance Mutation M184V/M184I
NCT02616029 ·Status: COMPLETED ·Phase: PHASE3
-
Advanced Neuroimaging Evaluation of CNS Changes Associated With Efavirenz Therapy Switch to an Raltegravir-based Regimen
NCT01978743 ·Status: COMPLETED ·Phase: NA
-
HIV Attachment Inhibitor to Treat Human Immunodeficiency Virus 1 (HIV-1) Infections
NCT01384734 ·Status: COMPLETED ·Phase: PHASE2
-
Enfuvirtide/Current Protease Inhibitor Switch to PREZISTA (Darunavir)/Ritonavir + TMC125 in HIV Patients With Enfuvirtide Side Effects.
NCT00460746 ·Status: COMPLETED ·Phase: PHASE3
-
Observational Study on Predictors of Response to Invirase (Saquinavir) Treatment in Treatment-naïve Patients With HIV Infection
NCT01297127 ·Status: COMPLETED
-
Switching From Protease Inhibitor (PI) to Etravirine in HIV-1 Infected Subjects With Viremia Suppression
NCT01034917 ·Status: COMPLETED ·Phase: PHASE3
-
Study to Evaluate the Efficacy and Safety of a Rilpivarine-based Antiretroviral Tratment Regimen in HIV- Infected Patients With Liver Metabolic Disease Who Maintain Udetectable HIV Viral Load
NCT05898841 ·Status: COMPLETED ·Phase: PHASE4