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

• Status: Completed
• Trial end date: 2015-02-01
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Lin, Hsi-Hsun, M.D.
• Treatments: HIV Protease Inhibitors; Protease Inhibitors; Raltegravir Potassium; Reverse Transcriptase Inhibitors

Criteria

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