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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000005116
Receipt No. R000006083
Scientific Title Switching from Lopinavir/Ritonavir Plus Tenofovir and Emtricitabine (or Lamivudine) to Darunavir (Prezista) and Raltegravir to Evaluate Renal Function
Date of disclosure of the study information 2011/02/21
Last modified on 2014/02/21

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Basic information
Public title Switching from Lopinavir/Ritonavir Plus Tenofovir and Emtricitabine (or Lamivudine) to Darunavir (Prezista) and Raltegravir to Evaluate Renal Function
Acronym SPARE Study
Scientific Title Switching from Lopinavir/Ritonavir Plus Tenofovir and Emtricitabine (or Lamivudine) to Darunavir (Prezista) and Raltegravir to Evaluate Renal Function
Scientific Title:Acronym SPARE Study
Region
Japan

Condition
Condition HIV infections, AIDS, HIV-1
Classification by specialty
Infectious disease
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The main objective of this trial to randomize HIV infected patients under good HIV control with tenofovir (TDF), emtricitabine (or lamivudine) and lopinavir/ritonavir (LPV/r) into an arm continuing the ongoing regimen or the other arm switching the regimen to raltegravir (RAL) with darunavir/ritonavir (DRV/r) 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 the patients' renal functions and has the same virological efficacy in comparison with a standard treatment with TDF, or not.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes 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.
Key secondary outcomes 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

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 An arm to change the regimen 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, Norvir soft-capsule 1 cap PC BID, and Isentress 1 tab PC BID

(Norvir soft-capsule may be substituted by Notvir tablet upon consultation)

from:
Kaletra 4 tabs QD and Truvada 1 tab QD
or
Kaletra 4 tabs QD, Viread 1 tab QD and Epivir300mg 1 tab (or Epivir 150mg 2 tabs) QD
Interventions/Control_2 An arm continuing on as 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 and Epivir300mg 1 tab (or Epivir 150mg 2 tabs) QD
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria HIV infected outpatients or inpatients that are:
1) without history virological failure including protease inhibitors or raltegravir (disregarding whether the patient had a history of drug resistance or drug holiday, or not)
2) taking LPV/r+TVD (or TDF+lamivudine) for longer than 15 weeks before the enrollment
3) 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).
4) 20 years old or older
5) Japanese
6) willing to participate in the trial and able to agree to the informed consent.
Key exclusion criteria 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
Target sample size 54

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shinichi Oka
Organization National Center for Global Health and Medicine
Division name AIDS Clinical Center
Zip code
Address 1-21-1 Toyama, Shinjuku, Tokyo JAPAN
TEL 03-5273-5193
Email oka@acc.ncgm.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takeshi Nishijima
Organization National Center for Global Health and Medicine
Division name AIDS Clinical Center
Zip code
Address 1-21-1 Toyama, Shinjuku, Tokyo JAPAN
TEL 03-3202-7181(5673)
Homepage URL
Email tnishiji@acc.ncgm.go.jp

Sponsor
Institute AIDS Clinical Center at National Center for Global Health and Medicine
Institute
Department

Funding Source
Organization Ministry of Health, Labour and Welfare (Japan)
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs YES
Study ID_1 NCT01294761
Org. issuing International ID_1 National Institutes of Health (NIH)
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 独立行政法人国立国際医療研究センター病院(東京都)

Other administrative information
Date of disclosure of the study information
2011 Year 02 Month 21 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2011 Year 01 Month 27 Day
Date of IRB
Anticipated trial start date
2011 Year 02 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2011 Year 02 Month 21 Day
Last modified on
2014 Year 02 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006083

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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