Status:
COMPLETED
Raltegravir With Optimized Background Therapy (OBT) in Multiple Experienced HIV-infected Patients
Lead Sponsor:
Doroana, Maria Manuela, M.D.
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Eurotrials Brasil Consultores Cientificos Ltda
Conditions:
HIV Infections
Eligibility:
All Genders
18+ years
Brief Summary
The purpose of this study is to evaluate the efficacy of raltegravir with optimized background therapy (OBT) in multiple-experienced HIV infected patients, measured by the proportion of patients with ...
Detailed Description
Considering its novel mechanism of action, potency, safety and tolerability, and pharmacokinetic profile, raltegravir has been used in several clinical scenarios. Since its initial clinical use in mul...
Eligibility Criteria
Inclusion
- Male or female patients, aged 18 years or older
- ARV multi-experienced patients (i.e. experienced at least two prior regimens) with need to change current ARV therapy, including:
- HIV-1 infected patients with documented therapeutic failure,
- HIV-2 infected patients with documented therapeutic failure
- HIV infected patients in virologic suppression who needed to change ARV due to inacceptable toxicity, as determined by the investigator, including patients who needed to replace T20
- Raltegravir-naïve patients who initiated raltegravir since the EAP Program, with optimized background therapy(OBT)
- Patient who has been followed at the same clinical site since the start of raltegravir
Exclusion
- Acute or decompensated chronic hepatitis. Patients with serum aminotransferase levels 10 times the upper limit of the normal range or higher (grade 4)
- Patients who presented resistance to drugs included in OBT (namely, etravirine, darunavir or maraviroc)
- Non-existing medical records for viral load and TCD4 at baseline, week 24 and 48
Key Trial Info
Start Date :
April 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 1 2010
Estimated Enrollment :
151 Patients enrolled
Trial Details
Trial ID
NCT01190124
Start Date
April 1 2010
End Date
July 1 2010
Last Update
May 19 2011
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