Measure of Pharmacokinetic Parameters and Adherence With MEMS in Naive HIV Infected Patients Treated With Reyataz Once Daily Combined With Norvir and Truvada
Phase 2
Completed
- Conditions
- HIV Infections
- Registration Number
- NCT00528060
- Lead Sponsor
- French National Agency for Research on AIDS and Viral Hepatitis
- Brief Summary
the trial assessed the pharmacokinetics and long term plasma exposure of the following antiretrovirals: atazanavir when combined to ritonavir and the tenofovir/emtricitabine fixed-dose combination. All drugs will be delivered in MEMS electronic device to monitor dosing history.
- Detailed Description
The trial is a phase II, open label, non-randomized, prospective multicenter trial to assess the pharmacokinetics and long term plasma exposure of the following antiretrovirals: atazanavir when combined to ritonavir and the tenofovir/emtricitabine fixed-dose combination. All drugs will be delivered in MEMS electronic device to monitor dosing history.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 35
Inclusion Criteria
- Naïve of treatment HIV -1 infected patients
- CD4 above 100/mm3
Exclusion Criteria
- pregnancy
- renal failure
- hepatitic disease
- ongoing opportunistic disease
- Hb under 8g/dl; platelets under 50 000/mm3; neutrophils under 750/mm3; Prothrombin index under 80%, Ca or Ph > 2.5 N
- drugs interacting with investigational drugs
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method pharmacokinetic parameters of atazanavir (ATV) when combined with ritonavir (RTV) and tenofovir/emtricitabine week 4
- Secondary Outcome Measures
Name Time Method pharmacokinetics of emtricitabine and tenofovir; intraindividual variability in ARVs concentrations; adherence measured with MEMS records and validated ANRS observance autoquestionnaire; relationships between virological response or side event occurrence Week 24
Trial Locations
- Locations (2)
Hopital du Kremlin Bicêtre Service de médecine interne
🇫🇷Kremlin Bicëtre, France
Hopital Bichat CIC
🇫🇷Paris cedex 18, France