Raltegravir Switch for Toxicity or Adverse Events (RaSTA)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2009 by Catholic University of the Sacred Heart.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Catholic University of the Sacred Heart
ClinicalTrials.gov Identifier:
NCT00958100
First received: August 12, 2009
Last updated: September 28, 2009
Last verified: August 2009

August 12, 2009
September 28, 2009
August 2009
November 2010   (final data collection date for primary outcome measure)
To verify the persistent control of the virus replication after the simplification to tenofovir+emtricitabine+raltegravir or to lamivudine+abacavir+raltegravir in patients with optimal virological suppression without any previous virological failure [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00958100 on ClinicalTrials.gov Archive Site
  • Time to virological failure (two consecutive HIV-RNA levels > 50 copies/mL or a single value >1000 copies/mL) at survival analysis [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
  • Proportion of patients with viral load lower than 50 copies/mL at 48 weeks at the intention to treat analysis [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
  • Evolution of CD4 cell count during the 48 weeks of study [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
  • Evolution of adherence and quality of life during the 48 weeks of study [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
  • Evolution of raltegravir plasma concentrations during the 48 weeks of study [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
  • Evolution of metabolic parameters during the 48 weeks of study [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
  • Change of the results of neurocognitive tests at 48 weeks of study [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
  • Change of bone density and of adipose tissue by DEXA analysis at 48 weeks of study [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Raltegravir Switch for Toxicity or Adverse Events
Phase IIb Pilot Study for the Evaluation of the Safety and the Feasibility of Treatment Simplification to Tenofovir+Emtricitabine+Raltegravir or to Lamivudine+Abacavir+Raltegravir in Patients With Optimal Virological Control and Toxicity to the Current Combined Antiretroviral Regimen

This study aims to verify the persistent control of the virus replication at 48 weeks after the simplification to tenofovir + emtricitabine + raltegravir or to lamivudine+abacavir+raltegravir in patients with optimal virological suppression without any virological failure to previous combined antiretroviral therapies needing a therapeutic switch for toxicity related issues or adverse events.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • HIV/AIDS
  • Antiretroviral Therapy
  • HIV Infections
  • Drug: tenofovir emtricitabine raltegravir
    switch from current antiretroviral regimen to raltegravir with tenofovir/emtricitabine as backbone
  • Drug: Lamivudine Abacavir Raltegravir
    Switch from current antiretroviral regimen to raltegravir with abacavir/lamivudine as backbone
  • Drug: Abacavir free
    Patients will receive raltegravir with tenofovir/emtricitabine; data will be added to those of Tenofovir Emtricitabine Raltegravir arm in a separate longitudinal analysis comparing data at baseline and at 48 weeks. In this separate analysis, data will not be compared to those obtained from the Lamivudine Abacavir Raltegravir arm. The number of patients in this arm is not pre-established.
  • Experimental: Tenofovir Emtricitabine Raltegravir
    Patients switching to raltegravir with tenofovir+emtricitabine as backbone
    Intervention: Drug: tenofovir emtricitabine raltegravir
  • Experimental: Lamivudine Abacavir Raltegravir
    Switch from current antiretroviral regimen to raltegravir with abacavir/lamivudine as backbone
    Intervention: Drug: Lamivudine Abacavir Raltegravir
  • Experimental: Abacavir free
    Patients switched to raltegravir whose backbone therapy should not be randomized in order to avoid the use of abacavir (HLA-B*5701 positive patients,Framingham score 20% or higher)
    Intervention: Drug: Abacavir free
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
40
December 2010
November 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients treated with a combined antiretroviral therapy from at least 1 year
  • Aged 18 years or older
  • With one or more of the following conditions:

    • Grade 3 or 4 Dyslipidemia
    • Any Hyperglycemia
    • Lipodystrophy (patient's self report, confirmed by physician's physical examination)
    • Moderate/severe cardiovascular risk, defined as a calcium score higher than 40 or a Framingham score higher than 10 (estimated 10 years cardiovascular risk: 10%)
    • Diarrhea (at least 3 emissions of loose stool every day for at least 3 days every week)
  • With at least two HIV-RNA levels <50 copies/mL on two consecutive determinations at least 3 months apart
  • With CD4 cell count >200 cells/ μL for at least 6 months and absence of any opportunistic infection or AIDS-related disease during the last year before screening.
  • Who gave informed consent to the participation to the study

Exclusion Criteria:

  • Pregnancy or breast feeding, desire of pregnancy in the short term
  • Previous virological failure (two consecutive HIV-RNA levels > 50 copies/mL or a single value >1000 copies/mL) to antiretroviral therapy and/or previous exposure to mono- or dual therapies with reverse transcriptase nucleoside analogues except for patients with subsequent genotypic resistance tests showing no resistance mutations to any of the study drugs.
  • Previous exposure to inhibitors of HIV-1 integrase
  • Previous major toxicity to any of the study drugs
  • Spontaneous treatment interruptions in disagreement with the treating physician in the last year or loss to follow-up for at least 6 months, at least once in the last two years
  • Current alcohol or drug abuse or any other condition which, in the judgment of the treating physician, may impair the patient's adherence to the new drug regimen and/or to the protocol's procedures
  • Patients with grade 3 or 4 laboratory abnormalities at screening (except for lipid and glucose levels)
Both
18 Years and older
No
Contact: Simona Di Giambenedetto, Dr 00390630154945 simona.digiambenedetto@rm.unicatt.it
Italy
 
NCT00958100
2009−014316−35
No
Simona Di Giambenedetto, CUSacredHeart
Catholic University of the Sacred Heart
Not Provided
Not Provided
Catholic University of the Sacred Heart
August 2009

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