HIV-1 infection
Conditions
Interventions
intensification with maraviroc for 24 weeks on standard ART regimen during early HIV-1 infection
Sponsors
National Hospital Organization Osaka National Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) HIV-1 infection with detected HIV-1 RNA 2) Incomplete HIV-1 Western blot on entry, or negative HIV-1 antibody within previous 1 year of entry 3) Written informed consent in Japanese is obtained 4) R5 HIV-1 as determined using the genotypic assay
Exclusion criteria
Exclusion criteria: 1) coronary diseases: unstable angina or history of acute myocardial infarction within 6 months before entry 2) Viral hepatitis (HBV,HCV) 3) Any verified Grade 4 laboratory abnormality (excluding abnormal lipid metabolism) 4)Alanine aminotransferase (ALT) greater than 5 times the upper limit of normal 5) Subject has creatinine clearance of less than 50 mL/min via Cockroft-Gault method 6)Any evidence of primary viral resistance based on the presence of any major resistance-associated mutation [IAS-USA, 2014] in the Screening result or, if known, any historical resistance test results 7) Women who are pregnant or sexually active without effective contraception 8) Subjects whom investigators consider to be inappropriate to enroll in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The number of patients achieving plasma viral load less than 50 copies/mL at week 48 | — |
Countries
Japan
Contacts
Public ContactYoko Nagasawa
National Hospital Organization Osaka National Hospital AIDS Medical Center
Outcome results
None listed