Raltegravir Switch for Toxicity or Adverse Events

• Status: Completed
• Trial end date: 2010-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Catholic University of the Sacred Heart
• Treatments: Abacavir; Dideoxynucleosides; Emtricitabine; Lamivudine; Raltegravir Potassium; Tenofovir

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)