HIV Infections
Conditions
Keywords
HIV infections, Salvage therapy, Amprenavir, Lopinavir, Ritonavir
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).
Interventions
Sponsors
Study design
Eligibility
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change of VIH RNA between week 0 and week 26 | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease progression | — |
| CD4 cell count | — |
| Safety | — |
| Pharmacokinetics | — |
| Genotypic resistance | — |
Countries
France
Contacts
Service des Maladies Infectieuses et Tropicales, Hôpital Saint-Antoine, Paris, France
INSERM U593, Bordeaux, France