Raltegravir Switch for Toxicity or Adverse Events

NCT ID: NCT00958100

Last Updated: 2015-02-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-08-31
• Study Completion Date: 2010-12-31

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.

Conditions

HIV/AIDS; Antiretroviral Therapy; HIV Infections

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Tenofovir Emtricitabine Raltegravir

Patients switching to raltegravir with tenofovir+emtricitabine as backbone

Group Type: EXPERIMENTAL

tenofovir emtricitabine raltegravir

Intervention Type: DRUG

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

Lamivudine Abacavir Raltegravir

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

Group Type: EXPERIMENTAL

Lamivudine Abacavir Raltegravir

Intervention Type: DRUG

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

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)

Group Type: EXPERIMENTAL

Abacavir free

Intervention Type: DRUG

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.

Interventions

tenofovir emtricitabine raltegravir

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

Intervention Type: DRUG

Lamivudine Abacavir Raltegravir

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

Intervention Type: 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.

Intervention Type: DRUG

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Catholic University of the Sacred Heart

OTHER

Sponsor Role: lead

Responsible Party

Simona Di Giambenedetto

Dr

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Policlinico A. Gemelli

Rome, , Italy

Countries

Italy

Other Identifiers

2009-014316-35

Identifier Type: -

Identifier Source: org_study_id