Salvage Therapy With Amprenavir, Lopinavir and Ritonavir in HIV-Infected Patients in Virological Failure.

• Status: Completed
• Trial end date: 2002-02-01
• Target enrollment: 0
• Participant gender: All

Summary

HIV infected patients are treated with highly active antiretroviral therapy (HAART). Side effects and the great number of pills reduces adherence to the treatment, and induces therapeutic failure. In order to maintain efficacy of HAART, new combination is evaluated. The aim of the study is to compare the antiviral efficacy of this salvage therapy combining lopinavir and amprenavir with 200 mg/d or 400 mg/d ritonavir, together with nucleoside reverse transcriptase inhibitors, over a 26-week period in HIV-infected patients in whom multiple antiretroviral regimens had failed.

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

Details

• Lead Sponsor: French National Agency for Research on AIDS and Viral Hepatitis
• Treatments: Amprenavir; Lopinavir; Ritonavir

Criteria

Inclusion Criteria:

• Documented HIV infection

• CD4 cell count below 300/mm3

• Plasma HIV RNA over 30,000 copies/ml

• Previously treated with 2 protease inhibitors and 1 non nucleoside analogue (except amprenavir, lopinavir)

• Written informed consent

Exclusion Criteria:

• Biological abnormalities

• Pregnancy

• Alcool abuse

• History of pancreatitis, hepatic failure

• Acute HIV related infection

• Chemotherapy