Status:
COMPLETED
Dual Therapy With Raltegravir and Darunavir/Ritonavir in HIV Infected Patients.
Lead Sponsor:
Hospital Clinic of Barcelona
Conditions:
Integrase Inhibitors, HIV; HIV PROTEASE INHIB
Eligibility:
All Genders
18-65 years
Brief Summary
While 3-drug regimens remain standard of care, concerns exist regarding the safety of multi-drug regimens taken for a lifetime. Problems with nucleoside analogue therapy prompted successful trials wit...
Detailed Description
Hypothesis * NRTI-sparing regimens are attractive options to avoid NRTI-associated toxicity and to provide a full active regimen in patients with some extent of NRTI resistance. * Raltegravir (RAL) a...
Eligibility Criteria
Inclusion
- Documented HIV infection
- Naïve to Raltegravir.
- CD4 cell count above 200 cell/mm3.
- No history of failure to PI containing regimens.
- No evidence of PI mutations (IAS-mutation list) by genotype test.
- Failing to a NRTI based regimen.
- The treating physician decides a NRTI sparing regimen which includes DRV/r 800/100 mg QD plus Raltegravir 400 mg BID.
- Signed informed consent form
- In opinion of the investigator, the patient should be considered clinically stable and could follow regular visits as scheduled per protocol.
Exclusion
- Patients receiving drugs considered contraindicated to Raltegravir and DRV/r. Contraindicated drugs are: rifampin, fenitoin, phenobarbital in the case of raltegravir. Pravastatin, astemizole, sildenafil, are contraindicated in combination with DRV/r.
- Pregnancy
- Documented PI mutations
Key Trial Info
Start Date :
May 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT01258374
Start Date
May 1 2010
End Date
December 1 2011
Last Update
September 27 2019
Active Locations (1)
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1
Hospital Clinic
Barcelona, Spain, 08036