NCT01294761

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
59

participants targeted

Target at P25-P50 for not_applicable hiv-infections

Timeline
Completed

Started Feb 2011

Typical duration for not_applicable hiv-infections

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2011

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

February 10, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 11, 2011

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

March 30, 2015

Status Verified

March 1, 2015

Enrollment Period

1 year

First QC Date

February 10, 2011

Last Update Submit

March 27, 2015

Conditions

HIV Infections

Keywords

HIV-1AIDSClinical Trials, Randomized

Outcome Measures

Primary Outcomes (1)

  • 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.

    48 weeks

Secondary Outcomes (6)

  • Virological efficacy

    48 weeks up to 96 weeks

  • Renal function markers

    48 weeks up to 96 weeks

  • Lipids

    48 weeks up to 96 weeks

  • Adverse events

    96 weeks

  • Blood plasma concentration of RAL and DRV

    96 weeks

  • +1 more secondary outcomes

Study Arms (2)

Raltegravir, Darunavir/r

EXPERIMENTAL

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

Tenofovir, Emtricitabine, Lopinavir/r

NO INTERVENTION

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

Interventions

Raltegravir, Darunavir/rDRUG

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

Also known as: NRTI sparing regimen
Raltegravir, Darunavir/r

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)
  • years old or older
  • Japanese
  • willing to participate in the trial and able to agree to the informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Center for Global Health and Medicine

Shinjuku, Tokyo, 1628655, Japan

Location

Related Publications (1)

  • 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.

    PMID: 23951362RESULT

MeSH Terms

Conditions

HIV InfectionsAcquired Immunodeficiency Syndrome

Interventions

Raltegravir Potassium

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesSlow Virus Diseases

Intervention Hierarchy (Ancestors)

PyrrolidinonesPyrrolidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Shinichi Oka, MD PhD

    National Center for Global Health and Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 10, 2011

First Posted

February 11, 2011

Study Start

February 1, 2011

Primary Completion

February 1, 2012

Study Completion

December 1, 2013

Last Updated

March 30, 2015

Record last verified: 2015-03

Locations

JP(1)