HIV
Conditions
Keywords
HIV, AIDS, MONOTHERAPY, PILOT, LOPINAVIR/RITONAVIR
Brief summary
Lopinavir/ritonavir monotherapy is currently a well known and widely used strategy, while Lopinavir/ritonavir 800/200 mg once a day in a triple-therapy was approved a few years ago. The purpose of this study is to evaluate efficacy and safety of Lopinavir/ritonavir 800/200 mg monotherapy once a day.
Interventions
DRUGLopinavir/ritonavir 800 mg / 200mg
Lopinavir/ritonavir 800 mg / 200mg will be change from its approved posology (2 times daily)to once daily in patients with undetectable viral load and in stable treatment with Lopinavir/ritonavir 800 mg / 200mg in monotherapy for at least 6 months
Sponsors
Daniel Podzamczer
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
* Patients older than 18, HIV positive * Patients receiving a monotherapy regimen (Lopinavir/ritonavir twice daily)during the last 6 months * Undetectable viral load (\<40 copies/ml) during the last 6 months * Patients that accept participation in the study and sign the Informed Consent Form * Childbearing females with negative pregnancy tests and using appropriate contraceptive measures
Exclusion criteria
* Opportunistic disease, cancer or any other active disease with specific treatment * Active addiction to illegal drugs or active use of psychotropic drugs * Mental retardation diagnosis, or mental dementia or severe psychiatric disorder (excluding major depression disorder solved \> 3 months) * Females who are breastfeeding or pregnant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| plasma viral load <40 copies/mL | Week 48 | HIV Plasma Viral Load \<40 copies/ml at week 48. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Stability in the plasma levels of Lopinavir/ritonavir during all study visits | Weeks 4, 8, 12, 16, 24, 36 and 48 | Determination of plasma concentrations of the study drug at weeks 4, 8, 12, 16, 24, 36 and 48 |
| Tolerability | Weeks 4, 8, 12, 16, 24, 36 and 48 | Possible Adverse Events will be collected in all study visits and laboratory tests will also be performed in all study visits (weeks 4, 8, 12, 16, 24, 36 and 48) |
| Adherence | Weeks 4, 8, 12, 16, 24, 36 and 48 | Medication adherence will be evaluated in all the study visits after making a reconciliation of the medication dispensed and returned by the patients |
| Satisfaction | Weeks 4, 8, 12, 16, 24, 36 and 48 | Patients' satisfaction with the new regimen will be evaluated using a questionnaire (SMAQ) |
| - Efficacy in CSF | At least 4 weeks on study treatment | \- In a subsample of patients (10) HIV-1 RNA in CSF will be assessed (added as per amendment) |
Countries
Spain
Outcome results
None listed