Amprenavir/Ritonavir, Saquinavir/Ritonavir or Efavirenz in HIV-Infected Subjects Following Failure With Kaletra (ABT-378/Ritonavir) as Their First Protease Inhibitor Based HAART

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to study amprenavir/ritonavir, saquinavir/ritonavir or efavirenz in HIV-infected patients following failure with Kaletra (ABT-378/ritonavir) as their first protease inhibitor based HAART.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Abbott
• Treatments: Amprenavir; Efavirenz; HIV Protease Inhibitors; Lopinavir; Protease Inhibitors; Ritonavir; Saquinavir

Criteria

Inclusion:

• Remain on present anti-HIV drugs during screening until a new regimen is started.

• Have a viral load of at least 1,000 copies/ml on the 2 most recent tests after at least 24 weeks of lopinavir/ritonavir and while still on it.

• Have an HIV which shows reduced susceptibility to lopinavir.

• Are at least 18 years old.

• Are not presently ill.

• Have not been treated for an opportunistic infection within 30 days of screening.

• Agree not to take certain drugs and agree to inform and get permission from the doctor before taking any medicines, over the counter medicines, herbal medicines, alcohol or recreational drugs.

• Agree to use an accepted barrier method of birth control.

Exclusion:

• Female subject is pregnant or lactating.

• Have taken any protease inhibitor other than lopinavir/ritonavir for more that two weeks.

• Are taking chemotherapy.

• Have a medical problem with their pancreas.

• Have been screened for this study within the past 12 weeks.

• Appear to be unsuitable in the opinion of the doctor.