HIV Infections
Conditions
Keywords
Once-a-day, Adherence, Nevirapine, Patient noncompliance, Administration and dosage, Treatment Experienced
Brief summary
Taking antiretrovirals once-a-day is considered the simpler way to improve adherence. However, it is not know if this assertion apply to patients taking their medication twice-a-day who change to once-a-day. We hypothesized that once-daily dosing improves adherence.
Interventions
BEHAVIORALNevirapine from twice-a-day to once-a-day
Sponsors
University Hospital, Caen
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
* HIV-1 infected adults receiving antiretroviral therapy including nevirapine twice-a-day for at least 6 months * plasma HIV RNA\<400 cp/ml during the previous 4 months on 2 occasions * accept adherence electronic monitoring * written informed consent signed
Exclusion criteria
* asparate aminotransferase (AST) or alanine aminotransferase (ALT) \>2.5N if hepatitis virus B or C were negative * AST or ALT\>1.25N if hepatitis virus B or C were positive
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| MEMS adherence by electronic devices | 28-week period (randomized phase) |
Secondary
| Measure | Time frame |
|---|---|
| Virologic efficacy (RNA HIV<400cp/ml) | — |
| Immunologic efficacy (CD4 count cells) | — |
| Tolerance (hepatic, cutaneous, ANRS safety grade scale) | — |
| Pharmacokinetics (nevirapine dosages) | — |
Outcome results
None listed