The primary objective of this pilot study is to assess the efficacy of lopinavir/ritonavir (Kaletra, a protease inhibitor, PI) when used in combination with maraviroc (Selzentry, an HIV entry inhibitor) for the treatment of antiretroviral naïve HIV infected patients. Twenty patients will be enrolled and studied for 48 weeks.
As patients with HIV are living longer it is important to explore antiretroviral treatments which may reduce the development of long term complications while preserving future HIV treatment options. This trial explores an antiretroviral treatment regimen which does not include the nucleoside reverse transcriptase inhibitor class which is thought to have long-term toxicity. This is a non-randomized, open label trial in participants meeting entry requirements. Participants will be evaluated at screening, baseline,and weeks 4, 8, 12, 24, 36, and 48 to include clinical assessments as well as laboratory assessments. An interim analysis will be performed when all patients have reached the week 24 visit.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
1
Lopinavir/ritonavir 400 mg/100 mg two tablets twice daily with Maraviroc 150 mg one tablet twice daily will be administered for 48 weeks to participants meeting entry criteria.
Temple General Internal Medicine
Philadelphia, Pennsylvania, United States
Assess Proportion of Participants With HIV RNA Levels <50 and < 400 Copies/mL.
Time frame: week 48
Number of Participants With HIV RNA < 50 and <400 Copies/ml.
Time frame: week 24
Assess the Proportion of Participants at Study Termination With VL < 50 Copies/ml.
Time frame: week 48
Determine the Time to Viral Suppression (VL < 50 Copies/ml).
Time frame: 48 weeks
Determine the Median Change in VL From Baseline to Week 24, to Week 48 and to Study Termination.
Time frame: week 24, week 48
Assess the Changes in CD4+ T Cell Count.
Time frame: week 24, 48
Assess Development of HIV Resistance Mutations and in HIV Co-receptor Tropism Changes in Participants Who Develop Virologic Rebound.
Time frame: week 48
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.