Clinical trial NCT00958100: Raltegravir Switch for Toxicity or Adverse Events
Official title: Phase IIb Pilot Study for the Evaluation of the Safety and the Feasibility of Treatment Simplification to Tenofovir+Emtricitabine+Raltegravir or to Lamivudine+Abacavir+Raltegravir in Patients With Optimal Virological Control and Toxicity to the Current Combined Antiretroviral Regimen
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: HIV/AIDS
Antiretroviral Therapy
HIV Infections
Keywords: raltegravir switch toxicity
treatment experienced
Lead sponsor: Catholic University of the Sacred Heart
Sponsor class: OTHER
First posted: 2009-08-13
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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)

Primary outcomes:
measure: 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
timeFrame: 48 weeks
Secondary outcomes:
measure: Time to virological failure (two consecutive HIV-RNA levels > 50 copies/mL or a single value >1000 copies/mL) at survival analysis
timeFrame: 48 weeks
measure: Proportion of patients with viral load lower than 50 copies/mL at 48 weeks at the intention to treat analysis
timeFrame: 48 weeks
measure: Evolution of CD4 cell count during the 48 weeks of study
timeFrame: 48 weeks
measure: Evolution of adherence and quality of life during the 48 weeks of study
timeFrame: 48 weeks
measure: Evolution of raltegravir plasma concentrations during the 48 weeks of study
timeFrame: 48 weeks
measure: Evolution of metabolic parameters during the 48 weeks of study
timeFrame: 48 weeks
measure: Change of the results of neurocognitive tests at 48 weeks of study
timeFrame: 48 weeks
measure: Change of bone density and of adipose tissue by DEXA analysis at 48 weeks of study
timeFrame: 48 weeks
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Policlinico A. Gemelli
Study officials:
References: