UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000005116
Receipt number 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 10:48:14

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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 or person

Institute

AIDS Clinical Center at National Center for Global Health and Medicine

Institute

Department

Personal name



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

Value
https://center6.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