CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 151 enrolled
Drug / intervention
Not specified
Likely dose
Not stated in record
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Search/NCT01190124
NCT01190124N/ACompleted

Raltegravir With Optimized Background Therapy (OBT) in Multiple Experienced HIV-infected Patients: a Retrospective Analysis of a Portuguese Cohort Treated Within the Expanded Access Program

Doroana, Maria Manuela, M.D.·observational·Posted Aug 27, 2010·Updated May 19, 2011

In Brief

An observational study for HIV Infections. Completed, enrolled 151 participants.

Detailed 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 undetectable viral load and the mean increase of CD4 cells count at week 24 and 48. It is also intended to evaluate: * viral load suppression and the mean increase of CD4 cells count at week 24 and 48 in patients who needed to change antiretroviral (ARV) therapy due to inacceptable toxicity, as determined by the investigator, including patients who needed to replace T20. * efficacy of raltegravir with OBT in HIV-2 infected patients that were included in this cohort, measured by the percentage of patients with undetectable viral load and the mean change of CD4 cells count at week 24 and 48. Study hypotheses: * Raltegravir with OBT is effective in achieving and maintaining a long term virologic suppression along with a significant increase on CD4 cells count in both HIV-1 and HIV-2 infected patients. * Patients who replaced T20 by raltegravir, due to intolerance, are able to maintain long term virologic suppression.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsHIV Infections
Countries--

Timeline

N/ACompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedAug 27, 2010
Enrollment StartApr 1, 2010
Primary CompletionJul 1, 2010
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 15.8 years ago