Raltegravir Switch for Toxicity or Adverse Events

NCT00958100 | Completed Phase 2

• 1 other identifier: 2009-014316-35
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Keywords

raltegravir switch toxicity; treatment experienced

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• 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

Study Arms (3)

Tenofovir Emtricitabine Raltegravir

EXPERIMENTAL

Patients switching to raltegravir with tenofovir+emtricitabine as backbone

Drug: tenofovir emtricitabine raltegravir

Lamivudine Abacavir Raltegravir

EXPERIMENTAL

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

Drug: Lamivudine Abacavir Raltegravir

Abacavir free

EXPERIMENTAL

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)

Drug: Abacavir free

Interventions

tenofovir emtricitabine raltegravir DRUG

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

Tenofovir Emtricitabine Raltegravir

Lamivudine Abacavir Raltegravir DRUG

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

Lamivudine Abacavir Raltegravir

Abacavir free 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.

Abacavir free

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Catholic University of the Sacred Heart: lead

Study Sites (1)

Policlinico A. Gemelli

Rome, 00168, Italy

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: August 12, 2009
• First Posted: August 13, 2009
• Study Start: August 1, 2009
• Primary Completion: November 1, 2010
• Study Completion: December 1, 2010
• Last Updated: February 4, 2015

Record last verified: 2015-02

Locations

IT (1)