Raltegravir Switch for Toxicity or Adverse Events

HIV Infections Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00958100
• Other study ID #: 2009-014316-35
• Status: Completed
• Phase: Phase 2
• First received: August 12, 2009
• Last updated: February 3, 2015
• Start date: August 2009
• Est. completion date: December 2010

Study information

• Verified date: February 2015
• Source: Catholic University of the Sacred Heart
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: The Italian Medicines Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Antiretroviral Therapy
• HIV Infections
• HIV/AIDS

Intervention

Drug:
• tenofovir emtricitabine raltegravir
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
• 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.

Locations

Country	Name	City	State
Italy	Policlinico A. Gemelli	Rome

Sponsors (1)

Lead Sponsor	Collaborator
Catholic University of the Sacred Heart

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Time to virological failure (two consecutive HIV-RNA levels > 50 copies/mL or a single value >1000 copies/mL) at survival analysis		48 weeks	No
Secondary	Proportion of patients with viral load lower than 50 copies/mL at 48 weeks at the intention to treat analysis		48 weeks	No
Secondary	Evolution of CD4 cell count during the 48 weeks of study		48 weeks	No
Secondary	Evolution of adherence and quality of life during the 48 weeks of study		48 weeks	No
Secondary	Evolution of raltegravir plasma concentrations during the 48 weeks of study		48 weeks	No
Secondary	Evolution of metabolic parameters during the 48 weeks of study		48 weeks	Yes
Secondary	Change of the results of neurocognitive tests at 48 weeks of study		48 weeks	Yes
Secondary	Change of bone density and of adipose tissue by DEXA analysis at 48 weeks of study		48 weeks	Yes