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

Phase 2

Completed

• Conditions: HIV Infections

• Registration Number: NCT00196625
• Lead Sponsor: French National Agency for Research on AIDS and Viral Hepatitis

Brief 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.

Detailed Description

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 (NRTI), over a 26-week period in HIV-infected patients in whom multiple antiretroviral regimens had failed. 100 patients with CD4 cell count below 300/mm3 and plasma HIV RNA over 30,000 copies/ml are to be included in four groups: amprenavir, lopinavir, NRTI, with ritonavir 200 mg.d or not (patients previously treated by additional ritonavir 200 or 400 mg/d).

Study Timeline

• Study Start: 2000-11
• Study Completion: 2002-02
• Status Verified: 2005-09
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Last Update Submitted: 2005-09-12
• Study First Posted: 2005-09-20
• Last Update Posted: 2005-09-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Mean change of VIH RNA between week 0 and week 26

Secondary Outcome Measures

Name	Time	Method
Disease progression
CD4 cell count
Safety
Pharmacokinetics
Genotypic resistance