HIV-1 Infection, HIV Infections
Conditions
Keywords
Treatment Experienced
Brief summary
Darunavir boosted with ritonavir (darunavir/r) is a powerful protease inhibitor, able to reduce the viral load in patients infected with multi-resistant HIV strains; In vitro and in vivo studies have shown that the induction of resistance mutations in the protease gene is much more difficult with the association darunavir/r compared to the other ritonavir-boosted protease inhibitors (PI/r), testifying of a significantly higher genetic barrier to resistance. Moreover, the tolerance to darunavir is good, and the pharmacologic profile of this molecule allows a once daily administration with a 800/100 mg dose in patients infected with a wild HIV strain or with a slightly resistant to darunavir/r strain. Thus, we propose to evaluate the efficacy of the darunavir/r association once daily as a substitute to a protease inhibitor regimen administered twice daily in patients with undetectable viral load receiving a tritherapy including a protease inhibitor administered twice daily.
Interventions
DRUGdarunavir
darunavir/r 800/100 mg once daily by oral route, 48 weeks of treatment
Sponsors
Centre de Recherches et d'Etude sur la Pathologie Tropicale et le Sida
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* HIV-1 infected patients * Treatment with an association of 3 molecules including two Nucleotidic Reverse Trasncriptase Inhibitors and a ritonavir-boosted protease inhibitor BID, unchanged for at least one month * At least two documented undetectable viral loads (under 50 copies/ml) within the last 3 months * Naiive from darunavir * Free from any opportunistic infection * Creatinin \< 3N * ASAT & ALAT \< 5N * Haemoglobin \> 7 g/dl * Platelets \> 50 000/mm3 * Negative pregnancy test for women of childbearing potential and use of a mechanic contraceptive during sexual relationships * Signed informed consent
Exclusion criteria
* HIV-2 infected patients * Treatment different from the association described in the inclusion criteria (2 NRTIs + 1 PI/r BID) * Patients with a documented problem of treatment compliance within the last 12 months * Ongoing active treatment against any opportunistic infection or tuberculosis * Any critic concomitant condition (alcohol consumption, fatigue) that may jeopardize treatment compliance and/olr tolerance, and interfere with the protocol compliance * Any concomitant treatment that may potentialize or inhibit hepatic cyotchrome-based enzymes * Patient already treated with darunavir * Patient treated with tipranavir, enfuvirtide, raltegravir, etravirine, and/or maraviroc
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Undetectable viral load ( < 50 copies/ml) | Week 24 |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of patients with undetectable viral load under 50 copies/ml | All visits |
| CD4 lymphocytes count and evolution | All visits |
| Lipids balance evolution | All visits |
| Proportion of patients in the situation of virologic failure defined as a viral load higher than 50 copies/ml confirmed with a second examen at least two weeks later. | All visits |
| Measure of the darunavir/r concentrations variability and correlation with the potential adverse events and/or virologic failures. | All visits |
| Spermatic viral load (sub-study concerning 15 patients) | Day 0 and Week 48 |
| Pharmacologic sub-studies | All visits |
| Treatment tolerance | All visits |
Countries
France
Outcome results
None listed