Efficacy and Safety of Raltegravir (RAL) in Treatment-experienced HIV-1 Infected Adult Chinese Patients
Recruitment status was Not yet recruiting
To assess the safety, tolerability and efficacy of Raltegravir (RAL) when combined with other antiretroviral drugs in treatment-experienced Chinese HIV-infected patients, including those with multi-drug resistant HIV-1 infection or drug intolerance.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||An Open Pilot Study to Evaluate the Efficacy and Safety, Tolerability of Raltegravir（RAL）in Treatment-experienced HIV-1 Infected Adult Chinese Patients|
- the safety and tolerability of RAL 400 mg b.i.d. in combination with optimized background therapy (OBT), assessed by review of the accumulated safety data in HIV-infected adult patients. [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
- antiretroviral activity of RAL 400 mg b.i.d. in combination with OBT as measured by change at week 24 in viral load from baseline, increase of CD4+ T lymphocytes compared to baseline [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||September 2010|
|Estimated Study Completion Date:||October 2012|
|Estimated Primary Completion Date:||May 2012 (Final data collection date for primary outcome measure)|
HIV-infected patients aged over 18 who have failed previous antiretroviral treatment with multi-drug resistant or with multi-drug intolerance are to accept Ral plus OBT.
RAL 400 mg twice daily plus OBT (optimized background therapy) for 48 weeks
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