Phase IIb pilot study for the evaluation of the safety and the feasibility of treatment simplification to tenofovir+emtricitabina+raltegravir or to lamivudine+abacavir+raltegravir in patients with optimal virological control and toxicity to the current combined antiretroviral regimen. - ND

Conditions: HIV
MedDRA version: 12.0Level: HLTClassification code 10038997Term: Retroviral infections

Registration Number: EUCTR2009-014316-35-IT

Lead Sponsor: POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

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 Hyperglicemia
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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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)