Completed

TaISENWITCHA Single Arm Study to Assess the Sustained Virological Suppression and Improvement of Treatment-emerged Adverse Events of Switching to Raltegravir in Stable HIV-infected Patients on Ritonavir-boosted Protease Inhibitor Regimen

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Raltegravir switch

Drug
Who is being recruted

Blood-Borne Infections+13

+ Urogenital Diseases

+ Genital Diseases

Over 20 Years
+17 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 4
Interventional
Study Start: July 2012
See protocol details

Summary

Principal SponsorLin, Hsi-Hsun, M.D.
Last updated: September 15, 2016
Sourced from a government-validated database.Claim as a partner

Study start date: July 1, 2012

Actual date on which the first participant was enrolled.

A. Objectives To compare the treatment-emerged AEs and virological suppression after switch to raltegravir-based therapy in stable HIV-infected patients who receiving ritonavir-boosted protease inhibitor antiretroviral regimen Primary endpoints: 1) The changes in overall incidence and severity of patient-reported clinical adverse events (based on "symptom distress module) after switch to raltegravir-based therapy. Secondary endpoints: The proportion of patients who are free of "virological failure" at week 48 after switch The change from baseline in CD4 cell counts at week 48 after switch The change in quality of life by assess the changes in the domain scores of MOS-HIV questionnaire at baseline and different study time points. The changes in laboratory adverse event, e.g., the mean percent changes from baseline to 48 weeks in plasma lipid profile (total cholesterol, LDLCholesterol, HDL Cholesterol, triglycerides) after switch The proportion of patients who are free of "treatment failure" at week 48 after switch Safety endpoints Incidence of adverse events The proportion of patients with treatment-related grade 3 or 4 adverse events and laboratory abnormalities

NCT01679964
Principal SponsorLin, Hsi-Hsun, M.D.
Last updated: September 15, 2016
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

107 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 20 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Blood-Borne InfectionsUrogenital DiseasesGenital DiseasesCommunicable DiseasesImmunologic Deficiency SyndromesImmune System DiseasesInfectionsRetroviridae InfectionsRNA Virus InfectionsSexually Transmitted DiseasesVirus DiseasesSexually Transmitted Diseases, ViralLentivirus InfectionsChemically-Induced DisordersHIV InfectionsDrug-Related Side Effects and Adverse Reactions

Criteria

5 inclusion criteria required to participate
Ages at least 20 years

Patient complained of treatment-emerged clinical adverse events or abnormal lipid profile

Patients are currently receiving a ritonavir-boosted PI-based regimen, including lopinavir, atazanavir, or darunavir, plus at least 2 antiretroviral agents (NRTIs)

Patients who are infected with HIV-1

Show More Criteria

12 exclusion criteria prevent from participating
Current alcohol or substance abuse (patients receiving methadone for the management of withdrawal symptoms due to substance abuse are allowed )

Patient with known history of contraindication or hypersensitivity to any component of the study regimen

Patient's viral load have not been consistently < 50 copies per ml for 6 months or longer

Patients have failed previous regimens (prior to starting the current 2NRTI+PI/r regimen they are currently on)

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Isentress (400mg) bid + 2 NRTI (at least 2 nucleoside or nucleotide reverse transcriptase inhibitors and no other protease inhibitors)

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 7 locations

E-Da Hospital

Kaohsiung, TaiwanOpen E-Da Hospital in Google Maps

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, Taiwan

China Medical University Hospital

Taichung, Taiwan

National Cheng Kung University Hospital

Tainan, Taiwan
Completed7 Study Centers