Safety Study of Lopinavir/Ritonavir With Raltegravir in HIV-infected Patients
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Safety and Efficacy of Lopinavir/Ritonavir in Combination With Raltegravir in HIV-infected Patients|
- The primary objective of this trial is to evaluate the percentage of patients with HIV-1 RNA below 50 copies at week 48 receiving lopinavir/ritonavir in combination with raltegravir [ Time Frame: week 48 ]
- To evaluate the effect of lopinavir/ritonavir in combination with raltegravir in maintaining virological suppression [ Time Frame: weeks 12, 24, 36, and 48 ]
- To evaluate the change from baseline in plasma HIV-1 RNA at weeks 12, 24, 36, and 48 [ Time Frame: weeks 12, 24, 36, and 48 ]
|Study Start Date:||September 2008|
|Study Completion Date:||June 2010|
|Primary Completion Date:||April 2010 (Final data collection date for primary outcome measure)|
open label single arm
Drug: lopinavir/ritonavir and raltegravir
lopinavir/ritonavir 400/100 mg po b.id. in combination with raltegravir 400 mg po b.i.d.
Other Name: Kaletra, Isentress
This is an open-labeled, non-randomized exploratory trial in selected volunteers who meet the stated enrollment criteria. This study will assess the impact of lopinavir/ritonavir in combination with raltegravir on HIV-1
Patients will be evaluated frequently over the 52 weeks of the protocol. Patients will be seen at screening, baseline, week 4, 12, 24, 36, 48, and 52, to include physical examination, assessment for the development of AIDS-defining conditions, hematology, chemistry, lipid profile, CD4, CD8 cell counts, plasma HIV-1 RNA ultrasensitive, and assessment of adverse events. If HIV-1 RNA becomes detectable, this will be repeated for confirmation with 2 weeks. HIV genotyping and phenotyping will be performed on patients who demonstrate repetitive plasma viral load levels of > 1,000 copies/mL.
An interim analysis will be performed when all patients have reached the week 24 visit.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00752037
|United States, New Jersey|
|Saint Michael's Medical Center|
|Newark, New Jersey, United States, 07102|
|Principal Investigator:||Jihad Slim, MD||Saint Michael's Medical Center|