Comparing Continuing Tenofovir, Emtricitabine (or Lamivudine) Plus Lopinavir and Switching to Raltegravir Plus Darunavir (SPARE)
HIV Infections

About this trial
This is an interventional treatment trial for HIV Infections focused on measuring HIV-1, AIDS, Clinical Trials, Randomized
Eligibility Criteria
Inclusion Criteria: HIV infected outpatients or inpatients that are
- without history virological failure including protease inhibitors or raltegravir (disregarding whether the patient had a history of drug resistance or drug holiday, or not)
- taking LPV/r+TVD (or TDF+lamivudine) for longer than 15 weeks before the enrollment
- with HIV viral load less than 50 copies/ml for 15 weeks, including those with blips (one time episode of detectable level HIV viraemia which are proceeded and followed by undetectable viraemia)
- 20 years old or older
- Japanese
- willing to participate in the trial and able to agree to the informed consent
Exclusion Criteria: cases applicable to any of the following will be excluded from this trial
- HBs antigen positive within 15 weeks to the enrollment (cases confirmed as HBs antibody positive can be enrolled without HBs antigen testing)
- malabsorption or gastrointestinal symptoms that affect absorption of the drugs, or dysphagia cases
- clinical data within 15 weeks before the start of the trial and of the closest date to the enrollment that are GPT 2.5 times the highest of the normal range (grade 2) or eGFR less than 60ml/min (Cockcroft-Gault formula)
- cases with opportunistic infections requiring treatment (primary and secondary preventive prophylaxis can be administrated during the study)
- cases during pregnancy or nursing period, or with a possibility for pregnancy
- using drugs that are prohibited to combine for drug interaction with the drugs of this trial
- other cases that are decided by the patient's physician as not suitable for the trial
Sites / Locations
- National Center for Global Health and Medicine
Arms of the Study
Arm 1
Arm 2
Experimental
No Intervention
Raltegravir, Darunavir/r
Tenofovir, Emtricitabine, Lopinavir/r
An arm to change the regimen from: Kaletra 4 tabs QD and Truvada 1 tab QD or Kaletra 4 tabs QD, Viread 1 tab QD, Epivir300mg 1 tab (or Epivir 150mg 2 tabs) QD to: Prezista naive 2 tabs PC QD, Norvir soft-capsule 1 cap PC QD and Isentress 1 tab BID or Prezista 2 tabs PC BID and Norvir soft-capsule 1 cap PC BID, and Isentress 1 tab BID
An arm continuing on the same regimen before the randomization as Kaletra 4 tabs QD and Truvada 1 tab QD or Kaletra 4 tabs QD, Viread 1 tab QD, Epivir300mg 1 tab (or Epivir 150mg 2 tabs) QD