Raltegravir Switch for Toxicity or Adverse Events (RaSTA)

Catholic University of the Sacred Heart

Status and phase: Completed; Phase 2

Conditions: Antiretroviral Therapy; HIV Infections; HIV/AIDS

Treatments: Drug: Abacavir free; Drug: Lamivudine Abacavir Raltegravir; Drug: tenofovir emtricitabine raltegravir

Study type: Interventional

Funder types: Other

Identifiers

NCT00958100

2009-014316-35

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

40 participants in 3 patient groups

Tenofovir Emtricitabine Raltegravir

Experimental group

Description:

Patients switching to raltegravir with tenofovir+emtricitabine as backbone

Treatment:

Drug: tenofovir emtricitabine raltegravir

Lamivudine Abacavir Raltegravir

Experimental group

Description:

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

Treatment:

Drug: Lamivudine Abacavir Raltegravir

Abacavir free

Experimental group

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)

Treatment:

Drug: Abacavir free