Sustained Virological Suppression and Improvement of Adverse Events of Switching to Raltegravir Study (TaISENWITCH)

Lin, Hsi-Hsun, M.D.

Status and phase

Completed

Phase 4

Conditions

Adverse Drug Reaction

Quality of Life

HIV Infection

Treatments

Drug: Raltegravir switch

Study type

Interventional

Identifiers

NCT01679964

MISP 40301 (Other Grant/Funding Number)

MISP40301

Details and patient eligibility

About

Switching from the ritonavir-boosted protease inhibitor component to raltegravir in stable HIV-infected adult patients receiving combination therapy will demonstrate improved clinical tolerability or lipid profiles with sustained plasma virological response (<50 copies/ml).

Full description

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:

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

Enrollment

107 patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients who are infected with HIV-1
Ages at least 20 years
Patients are currently receiving a ritonavir-boosted PI-based regimen, including lopinavir, atazanavir, or darunavir, plus at least 2 antiretroviral agents (NRTIs)
Patient complained of treatment-emerged clinical adverse events or abnormal lipid profile
Patients with plasma HIV-1 viral RNA below 50 copies per ml for at least 6 months

Exclusion criteria

Patient with known history of contraindication or hypersensitivity to any component of the study regimen
Patients with acute or decompensated chronic hepatitis in the previous 6 months
Patients with chronic hepatitis and serum aminotransferase concentrations are more than 5 times the upper limit of the normal range
Patients with renal insufficiency (patients need dialysis or have serum creatinine concentrations of more than twice the upper limit of the normal range
Current alcohol or substance abuse (patients receiving methadone for the management of withdrawal symptoms due to substance abuse are allowed )
Patients have failed previous regimens (prior to starting the current 2NRTI+PI/r regimen they are currently on)
Patient's viral load have not been consistently <50 copies per ml for 6 months or longer.
Patients initiated lipid lowering agents during the preceding 3 months
Patients with any medical disorder or history of any illness which, in the opinion of the investigator, that the use of study medications is contraindicated or might confound the results of the study or pose additional risk in administering study drugs to the patient
Pregnant, wish to become pregnant during the study period or breastfeeding women
Patients who are lack of expectation to maintain assigned study medication during study period
Patients who have received therapy with investigational drugs in the previous 3 months