NCT01679964

Brief Summary

Switching from the ritonavir-boosted protease inhibitor component to raltegravir in stable HIV-infected adult patients receiving combination therapy will demonstrate improved clinical tolerability or lipid profiles with sustained plasma virological response (\<50 copies/ml).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
107

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jul 2012

Typical duration for phase_4

Geographic Reach
1 country

7 active sites

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

July 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 30, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 6, 2012

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
Last Updated

September 15, 2016

Status Verified

September 1, 2016

Enrollment Period

2.6 years

First QC Date

August 30, 2012

Last Update Submit

September 14, 2016

Conditions

HIV InfectionAdverse Drug ReactionQuality of Life

Keywords

HIV infectionRaltegravirAdverse eventLife quality

Outcome Measures

Primary Outcomes (1)

  • The proportion of patient-reported clinical adverse events

    The proportion of patient-reported clinical adverse events in total and by severity (based on symptom distress module) at 4 weeks, The proportion of patient-reported clinical adverse events in total and by severity (based on symptom distress module) at 12-16 weeks, The proportion of patient-reported clinical adverse events in total and by severity (based on symptom distress module) at 28-32 weeks, The proportion of patient-reported clinical adverse events in total and by severity (based on symptom distress module) at 48 weeks

    Week 4, 12-16, 28-32, 48

Secondary Outcomes (5)

  • The proportion of patients who are free of "virological failure"

    Week 4, 12-16, 28-32, 48

  • The change from baseline in CD4 cell counts

    Week 4, 12-16, 28-32, 48

  • the change from baseline in life quality (based on the MOS-HIV questionnaire)

    week 12-16, 48

  • The percent changes from baseline in plasma lipid profiles (total cholesterol, LDL Cholesterol, HDL Cholesterol, triglycerides)

    Week 4, 12-16, 28-32, 48

  • The proportion of patients with treatment failure

    Week 4, 12-16, 28-32, 48

Study Arms (1)

Raltegravir switch

OTHER

Isentress (400mg) bid + 2 NRTI (at least 2 nucleoside or nucleotide reverse transcriptase inhibitors and no other protease inhibitors)

Drug: Raltegravir switch

Interventions

Raltegravir switchDRUG

Isentress (400mg) bid + 2 NRTI (at least 2 nucleoside or nucleotide reverse transcriptase inhibitors and no other protease inhibitors)

Also known as: Isentress
Raltegravir switch

Eligibility Criteria

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

You may qualify if:

  • Patients who are infected with HIV-1
  • Ages at least 20 years
  • Patients are currently receiving a ritonavir-boosted PI-based regimen, including lopinavir, atazanavir, or darunavir, plus at least 2 antiretroviral agents (NRTIs)
  • Patient complained of treatment-emerged clinical adverse events or abnormal lipid profile
  • Patients with plasma HIV-1 viral RNA below 50 copies per ml for at least 6 months

You may not qualify if:

  • Patient with known history of contraindication or hypersensitivity to any component of the study regimen
  • Patients with acute or decompensated chronic hepatitis in the previous 6 months
  • Patients with chronic hepatitis and serum aminotransferase concentrations are more than 5 times the upper limit of the normal range
  • Patients with renal insufficiency (patients need dialysis or have serum creatinine concentrations of more than twice the upper limit of the normal range
  • Current alcohol or substance abuse (patients receiving methadone for the management of withdrawal symptoms due to substance abuse are allowed )
  • Patients have failed previous regimens (prior to starting the current 2NRTI+PI/r regimen they are currently on)
  • Patient's viral load have not been consistently \<50 copies per ml for 6 months or longer.
  • Patients initiated lipid lowering agents during the preceding 3 months
  • Patients with any medical disorder or history of any illness which, in the opinion of the investigator, that the use of study medications is contraindicated or might confound the results of the study or pose additional risk in administering study drugs to the patient
  • Pregnant, wish to become pregnant during the study period or breastfeeding women
  • Patients who are lack of expectation to maintain assigned study medication during study period
  • Patients who have received therapy with investigational drugs in the previous 3 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

E-Da Hospital

Kaohsiung, Taiwan, 824, Taiwan

Location

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, 807, Taiwan

Location

China Medical University Hospital

Taichung, 40447, Taiwan

Location

National Cheng Kung University Hospital

Tainan, 704, Taiwan

Location

National Taiwan University Hospital

Taipei, 10048, Taiwan

Location

Taipei City Hospital

Taipei, 108, Taiwan

Location

Chang Gung Memorial Hospital at Linkou

Taoyuan District, 333, Taiwan

Location

Related Publications (1)

  • Walensky RP. The survival benefits of AIDS treatment in the US. J Infect Dis 2006;194:11-19 Lennox JL. Safety and efficacy of raltegravir-based versus efavirenz-based combination therapy in treatment-naive patients with HIV-1 infection. Lancet 2009;374:796-806 Steigbigel RT. Long-term efficacy and safety of Raltegravir combined with optimized background therapy in treatment-experienced patients with drug-resistant HIV infection. Clin Infect Dis 2010;50:605-12 Eron JJ. Switch to raltegravir-based regimen versus continuation of a lopinavir-ritonavir-based regimen in stable HIV-infected patients with suppressed viraemia (SWITCHMRK 1 and 2). Lancet 2010;375:396-407 Martinex E. Substitution of raltegravir for ritonavir-boosted protease inhibitors in HIV-infected patients: the SPIRAL study. AIDS 2010, 24:1697-1707 Division of AIDS(DAIDS). Toxicity guideline for adults. http://rcc.tech-res.com/safetyand pharmacovigilance(accessed Apr 15, 2011)

    BACKGROUND

MeSH Terms

Conditions

HIV InfectionsDrug-Related Side Effects and Adverse Reactions

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 DiseasesChemically-Induced Disorders

Intervention Hierarchy (Ancestors)

PyrrolidinonesPyrrolidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Hsi-Hsun Lin, MD

    E-DA Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDIV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 30, 2012

First Posted

September 6, 2012

Study Start

July 1, 2012

Primary Completion

February 1, 2015

Study Completion

February 1, 2015

Last Updated

September 15, 2016

Record last verified: 2016-09

Data Sharing

IPD Sharing
Will not share

Locations

TW(7)