A single center, open label, 48-week study of lopinavir/ritonavir in combination with raltegravir. 30 patients, both naïve and experienced, will be enrolled. 15 treatment naïve patients and 15 treatment experienced patients enrolled
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
lopinavir/ritonavir 400/100 mg po b.id. in combination with raltegravir 400 mg po b.i.d.
Saint Michael's Medical Center
Newark, New Jersey, United States
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
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