HIV Infections
Conditions
Keywords
HIV-1, Treatment simplification, Lopinavir/ritonavir, Treatment Experienced, HIV Seropositivity
Brief summary
The purpose of this study is to compare the efficacy and tolerance of a treatment simplification by a Lopinavir/ritonavir monotherapy versus continuation of current treatment in HIV-infected patients
Detailed description
Highly active antiretroviral therapy (HAART) has made a significant impact on the natural history of HIV-1 infection, but toxicities and complexities of therapy limit long-term efficacy, and make simpler yet effective HAART regimens highly desirable. Previous attempts to 'de-intensify' protease inhibitor (PI)-based therapy by discontinuing reverse transcriptase inhibitors (RTI) after achieving viral suppression met with failure, probably because plasma levels of most individually administered PI are too low to inhibit viral replication consistently. Low-dose ritonavir substantially enhances lopinavir plasma levels, and lopinavir/ritonavir (LPV/r) is effective as part of a combination therapy in both naive and PI-experienced patients. Furthermore, lopinavir is known to have a high genetic barrier to selection of resistance. LPV/r monotherapy could thus have the right combination of potency, favorable pharmacokinetics, and high genetic barrier needed to suppress viral replication and prevent the selection of lopinavir resistance. Preliminary results with maintenanceLPV/r monotherapy show interesting results but data from randomized studies are needed.
Interventions
DRUGLopinavir/ritonavir (drug)
Sponsors
Abbott
Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age \> or = 18 years * Confirmed HIV-1 seropositivity * Antiretroviral treatment stable since 3 months at least * HIV-1 ARN load \< 50 copies/mL since 6 months at least * Signed consent form * No history of treatment failure (= viral load \> 1000 copies/mL) including a protease inhibitor * No opportunistic infection in the previous 6 months
Exclusion criteria
* Neutrophils \< 750/mm3 * Hemoglobin \< 8 g/dL * Platelets \< 60,000/mm3 * Creatinin \> 150 micromoles/L * SGOT \> 5 NUL (Normal Upper Limit) * SGPT \> 5 NUL * Current IL-2 treatment * HBV infection treated or not by lamivudine or tenofovir * Pregnancy or feeding * Enrollment in another study not compliant with KALESOLO Study group assignment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of patients with a viral load < 50 copies/mL at S48 without any modification of antiretroviral treatment during study | W48 |
Secondary
| Measure | Time frame |
|---|---|
| Evolution of lymphocytes CD4 | W48 |
| Observance | W48 |
| Clinical and biological tolerance | W48 |
| Durability of viral response | W48 |
| Cost-efficacy ratio | W48 |
| Predictive value of proviral DNA before treatment simplification | W48 |
| Proportion of patients showing a lipodystrophy at J0 and S48 | W48 |
| Quantitative and qualitative changes in quality of life data | W48 |
Countries
France
Outcome results
None listed