NCT00438152

Lopinavir Capsules to Kaletra or Invirase Tablets

A 24-week, Randomized, Open-label, 2-arm Study to Compare the Safety, Efficacy and Tolerability of Invirase® Tablets With Ritonavir Versus Kaletra® Tablets in HIV 1 Infected Adults on a Kaletra® Based Regimen With 2 Nucleosides/Nucleotides

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 53 (actual)
• Sponsor: Royal Free Hampstead NHS Trust · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will compare the benefit for patients switching from Kaletra® to Invirase® tablets over remaining on Kaletra® (based on randomization), to elicit the lipid benefits inferred in previous studies

Detailed description

This is a prospective, phase IV, multicentre, randomised, open-label, 2-arm, 24-week study. Approximately 130 HIV-1 infected patients on a stable antiretroviral regimen containing Kaletra® with 2 nucleoside/nucleotide analogues will be randomized to 1 of 2 treatment arms: saquinavir with ritonavir 1000/100 mg BID (using Invirase® tablets) or lopinavir/ritonavir 400/100 mg BID (using Kaletra® tablets).Eligibility for enrollment will be determined at a screening visit that will occur within 30 days of the baseline visit. Protocol-defined study assessments will take place at clinic visits at the end of Weeks 4, 12, and 24.

Conditions

• HIV Infections

Interventions

Type	Name	Description
DRUG	Saquinavir (Invirase®)	Saquinavir 1000mg + Ritonavir 100mg Bd for 24 weeks
DRUG	Lopinavir/ritonavir (Kaletra®)	Lopinavir/ritonavir 400/100 mg BD 24 weeks

Timeline

• Start date: 2006-09-01
• Primary completion: 2009-02-01
• Completion: 2009-02-01
• First posted: 2007-02-21
• Last updated: 2011-07-18

Locations

1 site across 1 country: United Kingdom