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Comparing Continuing Tenofovir, Emtricitabine (or Lamivudine) Plus Lopinavir and Switching to Raltegravir Plus Darunavir (SPARE)
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Purpose
| Condition | Intervention |
|---|---|
| HIV Infections | Drug: Raltegravir, Darunavir/r |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Switching From Lopinavir/Ritonavir Plus Tenofovir and Emtricitabine (or Lamivudine) to Darunavir (Prezista) and Raltegravir to Evaluate Renal Function |
- eGFR improvement comparison of two arms by ITT analysis [ Time Frame: 48 weeks ]To investigate whether 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, or not.
- Virological efficacy [ Time Frame: 48 weeks up to 96 weeks ]Virological efficacy of the group on DRV/r+RAL
- Renal function markers [ Time Frame: 48 weeks up to 96 weeks ]Serum creatinine, eGFR, uine beta-2 microglobulin, tubular resorption rate of phosphate, urine albumin, N-acetyl-beta-glucosaminidase, serum cystatin C, urine protein and urine glucose
- Lipids [ Time Frame: 48 weeks up to 96 weeks ]Triglycerides, HDL cholesterol, LDL cholesterol and total cholesterol
- Adverse events [ Time Frame: 96 weeks ]Adverse events of each arm, symptoms and rate
- Blood plasma concentration of RAL and DRV [ Time Frame: 96 weeks ]Blood plasma concentration level of raltegravir and darunavir among all consented and intervened cases at National Center for Global Health and Medicine
- Discontinuation rate [ Time Frame: 96 weeks ]Discontinuation rate of each arm, reason and timing
| Enrollment: | 59 |
| Study Start Date: | February 2011 |
| Study Completion Date: | December 2013 |
| Primary Completion Date: | February 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Raltegravir, Darunavir/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 |
Drug: Raltegravir, Darunavir/r
An arm to change the regimen to: raltegravir and darunavir/ritonavir 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 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 Other Name: NRTI sparing regimen
|
|
No Intervention: Tenofovir, Emtricitabine, Lopinavir/r
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
|
Detailed Description:
Eligibility criteria are 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. Main outcome measures are 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 trial.
Other outcome measures are:
virological efficacy of the group on DRV/r+RAL (after 48 weeks and up to 96 weeks) 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) comparison of lipid markers between the two arms: triglycerides, HDL cholesterol, LDL cholesterol and total cholesterol (after 48 weeks and up to 96 weeks) discontinuation rate of each arm, reason and timing of the discontinuation or the treatment change up to 96 weeks adverse events of each arm, symptoms and rate up to 96 weeks blood plasma concentration level of RAL and DRV of all consented intervened cases at National Center for Global Health and Medicine
Eligibility| Ages Eligible for Study: | 20 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT01294761
| Japan | |
| National Center for Global Health and Medicine | |
| Shinjuku, Tokyo, Japan, 1628655 | |
| Principal Investigator: | Shinichi Oka, MD PhD | National Center for Global Health and Medicine |
More Information
Publications:
| Responsible Party: | National Center for Global Health and Medicine, Japan |
| ClinicalTrials.gov Identifier: | NCT01294761 History of Changes |
| Other Study ID Numbers: |
FWA00005823-SPARE2011 UMIN000005116 ( Other Identifier: University Hospital Medical Information Network (UMIN) ) |
| Study First Received: | February 10, 2011 |
| Last Updated: | March 27, 2015 |
Keywords provided by National Center for Global Health and Medicine, Japan:
|
HIV-1 AIDS Clinical Trials, Randomized |
Additional relevant MeSH terms:
|
HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Tenofovir Emtricitabine Lamivudine Raltegravir Potassium Lopinavir Darunavir |
Antiviral Agents Anti-Infective Agents Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Retroviral Agents Anti-HIV Agents HIV Integrase Inhibitors Integrase Inhibitors HIV Protease Inhibitors Protease Inhibitors Cytochrome P-450 CYP3A Inhibitors Cytochrome P-450 Enzyme Inhibitors |
ClinicalTrials.gov processed this record on June 22, 2017