Measure of Pharmacokinetic Parameters and Adherence With MEMS in Naive HIV Infected Patients Treated With Reyataz Once Daily Combined With Norvir and Truvada (ANRS134COPHAR3)

French National Agency for Research on AIDS and Viral Hepatitis

Status and phase: Completed; Phase 2

Conditions: HIV Infections

Treatments: Drug: Tenofovir/emtricitabine; Drug: Atazanavir; Drug: Ritonavir

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00528060

2007-003203-12

Details and patient eligibility

About

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.

Full 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.

Enrollment: 35 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)