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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2012 by National Center for Global Health and Medicine, Japan.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Ministry of Health, Labour and Welfare, Japan
Information provided by (Responsible Party):
National Center for Global Health and Medicine, Japan
ClinicalTrials.gov Identifier:
NCT01294761
First received: February 10, 2011
Last updated: January 16, 2012
Last verified: January 2012

February 10, 2011
January 16, 2012
February 2011
February 2012   (final data collection date for primary outcome measure)
eGFR improvement comparison of two arms by ITT analysis [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
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.
Same as current
Complete list of historical versions of study NCT01294761 on ClinicalTrials.gov Archive Site
  • Virological efficacy [ Time Frame: 48 weeks up to 96 weeks ] [ Designated as safety issue: Yes ]
    Virological efficacy of the group on DRV/r+RAL
  • Renal function markers [ Time Frame: 48 weeks up to 96 weeks ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    Triglycerides, HDL cholesterol, LDL cholesterol and total cholesterol
  • Adverse events [ Time Frame: 96 weeks ] [ Designated as safety issue: Yes ]
    Adverse events of each arm, symptoms and rate
  • Blood plasma concentration of RAL and DRV [ Time Frame: 96 weeks ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    Discontinuation rate of each arm, reason and timing
Same as current
Not Provided
Not Provided
 
Comparing Continuing Tenofovir, Emtricitabine (or Lamivudine) Plus Lopinavir and Switching to Raltegravir Plus Darunavir
Switching From Lopinavir/Ritonavir Plus Tenofovir and Emtricitabine (or Lamivudine) to Darunavir (Prezista) and Raltegravir to Evaluate Renal Function

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.

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

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
HIV Infections
Drug: Switching regimen to raltegravir and darunavir/ritonavir

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 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
  • 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

    Intervention: Drug: Switching regimen to raltegravir and darunavir/ritonavir
  • No Intervention: Tenofovir, Emtricitabine (or 3TC), 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
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;8(8):e73639. doi: 10.1371/journal.pone.0073639.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
54
February 2013
February 2012   (final data collection date for primary outcome measure)

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
Both
20 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT01294761
FWA00005823-SPARE2011, UMIN000005116
Yes
National Center for Global Health and Medicine, Japan
National Center for Global Health and Medicine, Japan
Ministry of Health, Labour and Welfare, Japan
Principal Investigator: Shinichi Oka, MD PhD National Center for Global Health and Medicine
National Center for Global Health and Medicine, Japan
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP