Who is sponsoring NCT01190124?

NCT01190124 is sponsored by Doroana, Maria Manuela, M.D..

What condition does NCT01190124 study?

NCT01190124 studies HIV Infections.

What is the status of NCT01190124?

NCT01190124 is currently COMPLETED.

Last reviewed 2011-04-20 · How we verify

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

NCT01190124 COMPLETED Results posted

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.

Details

Lead sponsor	Doroana, Maria Manuela, M.D.
Status	COMPLETED
Enrolment	151
Start date	2010-04
Completion	2010-07

Conditions

HIV Infections

Primary outcomes

HIV-RNA Levels — Baseline
Patients with undetectable viral load (confirmed HIV RNA \< 50 copies/mL) at baseline.
HIV-RNA Levels — week 24
Patients achieving undetectable viral load (confirmed HIV RNA \< 50 copies/mL) at week 24.
HIV-RNA Levels — week 48
Patients achieving undetectable viral load (confirmed HIV RNA \< 50 copies/mL) at week 48.
CD4 Cells Count — Baseline
CD4 cells count at baseline.
CD4 Cells Count — week 24
CD4 cells count at week 24.
CD4 Cells Count — week 48
CD4 cells count at week 48.