Raltegravir Switch for Toxicity or Adverse Events

Phase 2

Completed

• Conditions: Antiretroviral Therapy; HIV/AIDS; HIV Infections
• Interventions: Drug: tenofovir emtricitabine raltegravir; Drug: Abacavir free; Drug: Lamivudine Abacavir Raltegravir

• Registration Number: NCT00958100
• Lead Sponsor: Catholic University of the Sacred Heart

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-08
• Study First Submitted: 2009-08-12
• Study First Submitted QC: 2009-08-12
• Study First Posted: 2009-08-13
• Primary Completion: 2010-11
• Study Completion: 2010-12
• Status Verified: 2015-02
• Last Update Submitted: 2015-02-03
• Last Update Posted: 2015-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tenofovir Emtricitabine Raltegravir	tenofovir emtricitabine raltegravir	Patients switching to raltegravir with tenofovir+emtricitabine as backbone
Abacavir free	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)
Lamivudine Abacavir Raltegravir	Lamivudine Abacavir Raltegravir	Switch from current antiretroviral regimen to raltegravir with abacavir/lamivudine as backbone

Primary Outcome Measures

Name	Time	Method
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	48 weeks

Secondary Outcome Measures

Name	Time	Method
Time to virological failure (two consecutive HIV-RNA levels > 50 copies/mL or a single value >1000 copies/mL) at survival analysis	48 weeks
Proportion of patients with viral load lower than 50 copies/mL at 48 weeks at the intention to treat analysis	48 weeks
Evolution of CD4 cell count during the 48 weeks of study	48 weeks
Evolution of adherence and quality of life during the 48 weeks of study	48 weeks
Evolution of raltegravir plasma concentrations during the 48 weeks of study	48 weeks
Evolution of metabolic parameters during the 48 weeks of study	48 weeks
Change of the results of neurocognitive tests at 48 weeks of study	48 weeks
Change of bone density and of adipose tissue by DEXA analysis at 48 weeks of study	48 weeks

Trial Locations

Locations (1)

Policlinico A. Gemelli; 🇮🇹 Rome, Italy