Clinical validation of a CYP2B6 pharmacogenetics test and dosing algorithm in the safe and efficacious use of Efavirenz and its cost effective & benefit analysis in a public healthcare setting

Phase 2

• Conditions: HIV/AIDS

• Registration Number: PACTR202105618971235

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-04-27
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 260

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

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 <500 celss per ul
ii. Haemoglobin <7.0 g/dl
iii. Platelet count <50 000 cells per ul
iv. Aspartate aminotransferase, or alanine aminotransferase, or both >5 times the upper limit normal

Study & Design

• Study Type: Interventional
• Study Design: Not specified