Antiretroviral Therapy, HIV/AIDS, HIV Infections
Conditions
Keywords
raltegravir switch toxicity, treatment experienced
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.
Interventions
DRUGtenofovir emtricitabine raltegravir
switch from current antiretroviral regimen to raltegravir with tenofovir/emtricitabine as backbone
DRUGLamivudine Abacavir Raltegravir
Switch from current antiretroviral regimen to raltegravir with abacavir/lamivudine as backbone
DRUGAbacavir free
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.
Sponsors
Catholic University of the Sacred Heart
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
| Time to virological failure (two consecutive HIV-RNA levels > 50 copies/mL or a single value >1000 copies/mL) at survival analysis | 48 weeks |
| Evolution of metabolic parameters during the 48 weeks of study | 48 weeks |
| Change of the results of neurocognitive tests at 48 weeks of study | 48 weeks |
| Change of bone density and of adipose tissue by DEXA analysis at 48 weeks of study | 48 weeks |
| Evolution of raltegravir plasma concentrations during the 48 weeks of study | 48 weeks |
Countries
Italy
Outcome results
None listed