Switching from Lopinavir/Ritonavir Plus Tenofovir and Emtricitabine (or Lamivudine) to Darunavir (Prezista) and Raltegravir to Evaluate Renal Functio
- Conditions
- HIV infections, AIDS, HIV-1
- Registration Number
- JPRN-UMIN000005116
- Lead Sponsor
- AIDS Clinical Center at National Center for Global Health and Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 54
Not provided
Cases applicable to any of the following will be excluded from this trial: 1) HBs antigen positive within 15 weeks to the enrollment (cases confirmed as HBs antibody positive can be enrolled without HBs antigen testing) 2) Malabsorption or gastrointestinal symptoms that affect absorption of the drugs, or dysphagia cases 3) Clinical data within 15 weeks before the start of the trial and of the closest date to the enrollment that are: a. GPT 2.5 times the highest of the normal range (grade 2) b. eGFR less than 60ml/min (Cockcroft-Gault formula) 4) Cases with opportunistic infections requiring treatment (primary and secondary preventive prophylaxis can be administrated during the study) 5) Cases during pregnancy or nursing period, or with a possibility for pregnancy 6) Using drugs that are prohibited to combine for drug interaction with the drugs of this trial 7) Other cases that are decided by the patient's physician as not suitable for the trial
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To investigate if the estimated glomerular filtration rate (eGFR) of the intervened group with RAL+DRV/r improves by 10% or more by intention to treat (ITT) analysis at the time of 48 weeks after the start of the study.
- Secondary Outcome Measures
Name Time Method 1) Virological efficacy of the group on DRV/r+RAL (after 48 weeks and up to 96 weeks) 2) Comparison of other renal function markers between the two arms: serum creatinine, urine beta-2 microglobulin, tubular resorption rate of phosphate, urine albumin, N-acetyl-beta-glucosaminidase, serum cystatin C, urine protein and urine glucose (after 48 weeks and up to 96 weeks) 3) Comparison of lipid markers between the two arms: triglycerides, HDL cholesterol, LDL cholesterol and total cholesterol (after 48 weeks and up to 96 weeks) 4) Discontinuation rate of each arm, reason and timing of the discontinuation or the treatment change up to 96 weeks 5) Adverse events of each arm, symptoms and rate up to 96 weeks 6) Blood plasma concentration level of RAL and DRV of all consented intervened cases at National Center for Global Health and Medicine