Status:
COMPLETED
Raltegravir Switch for Toxicity or Adverse Events
Lead Sponsor:
Catholic University of the Sacred Heart
Conditions:
HIV/AIDS
Antiretroviral Therapy
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 patie...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00958100
Start Date
August 1 2009
End Date
December 1 2010
Last Update
February 4 2015
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Policlinico A. Gemelli
Rome, Italy, 00168