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Raltegravir Switch for Toxicity or Adverse Events (RaSTA)

Primary Purpose

HIV/AIDS, Antiretroviral Therapy, HIV Infections

Status

Completed

Phase

Phase 2

Locations

Italy

Study Type

Interventional

Intervention

tenofovir emtricitabine raltegravir

Lamivudine Abacavir Raltegravir

Abacavir free

About this trial

This is an interventional treatment trial for HIV/AIDS focused on measuring raltegravir switch toxicity, treatment experienced

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

Policlinico A. Gemelli

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

Tenofovir Emtricitabine Raltegravir

Lamivudine Abacavir Raltegravir

Abacavir free

Arm Description

Patients switching to raltegravir with tenofovir+emtricitabine as backbone

Switch from current antiretroviral regimen to raltegravir with abacavir/lamivudine as backbone

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)

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Time to virological failure (two consecutive HIV-RNA levels > 50 copies/mL or a single value >1000 copies/mL) at survival analysis

Proportion of patients with viral load lower than 50 copies/mL at 48 weeks at the intention to treat analysis

Evolution of CD4 cell count during the 48 weeks of study

Evolution of adherence and quality of life during the 48 weeks of study

Evolution of raltegravir plasma concentrations during the 48 weeks of study

Evolution of metabolic parameters during the 48 weeks of study

Change of the results of neurocognitive tests at 48 weeks of study

Change of bone density and of adipose tissue by DEXA analysis at 48 weeks of study

Full Information

NCT ID

NCT00958100

First Posted

August 12, 2009

Last Updated

February 3, 2015

Sponsor

Catholic University of the Sacred Heart

1. Study Identification

Unique Protocol Identification Number

NCT00958100

Brief Title

Raltegravir Switch for Toxicity or Adverse Events

Acronym

RaSTA

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2015

Overall Recruitment Status

Completed

Study Start Date

August 2009 (undefined)

Primary Completion Date

November 2010 (Actual)

Study Completion Date

December 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Catholic University of the Sacred Heart

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

HIV/AIDS, Antiretroviral Therapy, HIV Infections

Keywords

raltegravir switch toxicity, treatment experienced

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Tenofovir Emtricitabine Raltegravir

Arm Type

Experimental

Arm Description

Patients switching to raltegravir with tenofovir+emtricitabine as backbone

Arm Title

Lamivudine Abacavir Raltegravir

Arm Type

Experimental

Arm Description

Switch from current antiretroviral regimen to raltegravir with abacavir/lamivudine as backbone

Arm Title

Abacavir free

Arm Type

Experimental

Arm Description

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 Type

Drug

Intervention Name(s)

tenofovir emtricitabine raltegravir

Intervention Description

switch from current antiretroviral regimen to raltegravir with tenofovir/emtricitabine as backbone

Intervention Type

Drug

Intervention Name(s)

Lamivudine Abacavir Raltegravir

Intervention Description

Switch from current antiretroviral regimen to raltegravir with abacavir/lamivudine as backbone

Intervention Type

Drug

Intervention Name(s)

Abacavir free

Intervention Description

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.

Primary Outcome Measure Information:

Title

Time Frame

48 weeks

Secondary Outcome Measure Information:

Title

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

Title

Proportion of patients with viral load lower than 50 copies/mL at 48 weeks at the intention to treat analysis

Time Frame

48 weeks

Title

Evolution of CD4 cell count during the 48 weeks of study

Time Frame

48 weeks

Title

Evolution of adherence and quality of life during the 48 weeks of study

Time Frame

48 weeks

Title

Evolution of raltegravir plasma concentrations during the 48 weeks of study

Time Frame

48 weeks

Title

Evolution of metabolic parameters during the 48 weeks of study

Time Frame

48 weeks

Title

Change of the results of neurocognitive tests at 48 weeks of study

Time Frame

48 weeks

Title

Change of bone density and of adipose tissue by DEXA analysis at 48 weeks of study

Time Frame

48 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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)

Facility Information:

Facility Name

Policlinico A. Gemelli

City

Rome

ZIP/Postal Code

00168

Country

Italy

12. IPD Sharing Statement

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Raltegravir Switch for Toxicity or Adverse Events

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