HIV infection MedDRA version: 14.0 Level: PT Classification code 10020161 Term: HIV infection System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Trade Name: Efamat200
Product Name: Efavirenz
Pharmaceutical Form: Tablet
INN or Proposed INN: EFAVIRENZ
CAS Number: 154598-52-4
Sponsors
National Centre in HIV Epidemiology and Clinical Research
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • HIV-1 positive by licensed diagnostic test • aged >16 years of age (or minimum age as determined by local regulations or as legal requirements dictate) • 50 =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • the following laboratory values: - absolute neutrophil count (ANC) 5 x ULN • pregnant women or nursing mothers • active opportunistic or malignant disease not under adequate control • use of immunomodulators within 30 days prior to screening • use of any prohibited medications • current alcohol or illicit substance use that might adversely affect study participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the safety and efficacy of standard (600mg qd) versus reduced dose (400mg qd) EFV as part of initial combination antiretroviral therapy (ART).; Secondary Objective: To conduct a range of analyses to examine: • Virological response to therapy • Changes in CD4+ T cell numbers • Incidence and type of SAEs • Incidence and type of AEs • Changes from baseline in fasted lipid, glucose and selected serum biochemical parameters • Adherence to therapy • Quality of life • Neurocognitive function • Exploratory use of dry blood spot method to measure viral load and EFV concentrations ;Primary end point(s): The primary endpoint is the comparison between treatment groups of proportions of patients with HIV-1 RNA <200 copies/mL 48weeks after randomisation. | — |
Countries
Germany, United Kingdom
Outcome results
None listed