HIV/AIDS
Conditions
Interventions
Efavirenz
Sponsors
African Institute of Biomedical Science and Technology
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. HIV infected adults between 18 and 50 years 2. CD4 T-cell counts between 50-500 cells per ul 3. No previous AIDS defining illness 4. Plasma HIV-1 RNA of at least 1000 copies per ml 5. No short course for preventing mother to child transmission 6. No previous exposure to antiretroviral therapy
Exclusion criteria
Exclusion criteria: 1. Pregnancy or nursing mothers 2. Had uncontrolled active opportunistic or malignant disease 3. Present or recent use of prohibited or elicit medications adversely affecting participation 4. Laboratory values outside predefined ranges - i. Absolute neutrophil count 5 times the upper limit normal
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. viral load as a measure of regimen efficacy. This will be determined by qRT-PCR 2. Incidences and severity of neuropsychiatric adverse drug reactions this will be determined by neuropsychiatric adverse effects evaluation tools | — |
Secondary
| Measure | Time frame |
|---|---|
| Efavirenz plasma concentrations and correlations with CYP2B6 genotype and relation to neuropsychiatric side effects. The EFV concentrations will be determined by LC-MSMS and the CYP2B6 genotype by the QRTPCR method, which will have been validated in this study. | — |
Countries
Zimbabwe
Contacts
Public ContactRoslyn Thelingwani
Pharmacologist
Outcome results
None listed