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

Primary Purpose

HIV Infections

Status
Completed
Phase
Not Applicable
Locations
Japan
Study Type
Interventional
Intervention
Raltegravir, Darunavir/r
Sponsored by
National Center for Global Health and Medicine, Japan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring HIV-1, AIDS, Clinical Trials, Randomized

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Arm Type

Experimental

No Intervention

Arm Label

Raltegravir, Darunavir/r

Tenofovir, Emtricitabine, Lopinavir/r

Arm Description

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

Outcomes

Primary Outcome Measures

eGFR improvement comparison of two arms by ITT analysis
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.

Secondary Outcome Measures

Virological efficacy
Virological efficacy of the group on DRV/r+RAL
Renal function markers
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
Triglycerides, HDL cholesterol, LDL cholesterol and total cholesterol
Adverse events
Adverse events of each arm, symptoms and rate
Blood plasma concentration of RAL and DRV
Blood plasma concentration level of raltegravir and darunavir among all consented and intervened cases at National Center for Global Health and Medicine
Discontinuation rate
Discontinuation rate of each arm, reason and timing

Full Information

First Posted
February 10, 2011
Last Updated
March 27, 2015
Sponsor
National Center for Global Health and Medicine, Japan
Collaborators
Ministry of Health, Labour and Welfare, Japan
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1. Study Identification

Unique Protocol Identification Number
NCT01294761
Brief Title
Comparing Continuing Tenofovir, Emtricitabine (or Lamivudine) Plus Lopinavir and Switching to Raltegravir Plus Darunavir
Acronym
SPARE
Official Title
Switching From Lopinavir/Ritonavir Plus Tenofovir and Emtricitabine (or Lamivudine) to Darunavir (Prezista) and Raltegravir to Evaluate Renal Function
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
February 2011 (undefined)
Primary Completion Date
February 2012 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Center for Global Health and Medicine, Japan
Collaborators
Ministry of Health, Labour and Welfare, Japan

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The main objective of this clinical trial in randomizing HIV infected patients under good HIV control with tenofovir (TDF), emtricitabine (or lamivudine) plus lopinavir/ritonavir (LPV/r) into switching the regimen to raltegravir (RAL) with darunavir/ritonavir (DRV/r) or continuing the ongoing regimen to compare these two groups' estimated glomerular filtration rate (eGFR) is to investigate whether anti-HIV treatment that does not contain TDF or other reverse-transcriptase inhibitors (NTRI sparing regimen) can be protective of patients' renal functions and has the same virological efficacy in comparison with a standard treatment with TDF, or not.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
HIV-1, AIDS, Clinical Trials, Randomized

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
59 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Raltegravir, Darunavir/r
Arm Type
Experimental
Arm Description
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
Arm Title
Tenofovir, Emtricitabine, Lopinavir/r
Arm Type
No Intervention
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Raltegravir, Darunavir/r
Other Intervention Name(s)
NRTI sparing regimen
Intervention Description
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
Primary Outcome Measure Information:
Title
eGFR improvement comparison of two arms by ITT analysis
Description
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.
Time Frame
48 weeks
Secondary Outcome Measure Information:
Title
Virological efficacy
Description
Virological efficacy of the group on DRV/r+RAL
Time Frame
48 weeks up to 96 weeks
Title
Renal function markers
Description
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
Time Frame
48 weeks up to 96 weeks
Title
Lipids
Description
Triglycerides, HDL cholesterol, LDL cholesterol and total cholesterol
Time Frame
48 weeks up to 96 weeks
Title
Adverse events
Description
Adverse events of each arm, symptoms and rate
Time Frame
96 weeks
Title
Blood plasma concentration of RAL and DRV
Description
Blood plasma concentration level of raltegravir and darunavir among all consented and intervened cases at National Center for Global Health and Medicine
Time Frame
96 weeks
Title
Discontinuation rate
Description
Discontinuation rate of each arm, reason and timing
Time Frame
96 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shinichi Oka, MD PhD
Organizational Affiliation
National Center for Global Health and Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Center for Global Health and Medicine
City
Shinjuku
State/Province
Tokyo
ZIP/Postal Code
1628655
Country
Japan

12. IPD Sharing Statement

Citations:
PubMed Identifier
23951362
Citation
Nishijima T, Gatanaga H, Shimbo T, Komatsu H, Endo T, Horiba M, Koga M, Naito T, Itoda I, Tei M, Fujii T, Takada K, Yamamoto M, Miyakawa T, Tanabe Y, Mitsuya H, Oka S; SPARE study team. Switching tenofovir/emtricitabine plus lopinavir/r to raltegravir plus Darunavir/r in patients with suppressed viral load did not result in improvement of renal function but could sustain viral suppression: a randomized multicenter trial. PLoS One. 2013 Aug 8;8(8):e73639. doi: 10.1371/journal.pone.0073639. eCollection 2013.
Results Reference
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Comparing Continuing Tenofovir, Emtricitabine (or Lamivudine) Plus Lopinavir and Switching to Raltegravir Plus Darunavir

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