Human immunodeficiency virus (HIV) Infections and Infestations Human immunodeficiency virus
Conditions
Interventions
Study patients on nevirapine should be receiving 200 mg 12-hourly. Study patients on efavirenz who are taking 600 mg at night would be converted to 600 mg in the morning as follows: 400 mg mane, 200 m
Sanofi Synthelabo, Guildford, United Kingdom) and would self-administer the remaining dose at home for the remaining 6 days.
Joint sponsor details:
The University of L
Sponsors
Royal Liverpool University Hospital and the University of Liverpool?s Biomedical Research Centre (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged greater than 18 years, either sex 2. On efavirenz (EFV) or nevirapine (NVP) containing regimen for greater than or equal to 6 months 3. Viral load less than or equal to 40 copies/ml and any CD4 count 4. No laboratory evidence of NNRTI toxicity: 4.1. Alanine aminotransferase (ALT) less than or equal to upper limit of normal (ULN) 4.2. Bilirubin less than or equal to ULN 4.3. Albumin greater than or equal to 30 g 4.4. Creatinine less than or equal to ULN 5. Not pregnant (for contraception, patients would be advised to use non-oestrogen based contraceptive devices) 6. No inter-current acute illness 7. No past medical history of coronary heart disease 8. No history of bleeding diathesis 9. No history of allergy to thienopyridines
Exclusion criteria
Exclusion criteria: 1. Unable to provide informed consent 2. Known or suspected poor adherence to anti-retroviral therapy (ART) 3. Continuing intravenous (IV) drug user 4. On a HIV protease inhibitor or any known P450 inhibitors or inducers 5. Platelets less than or equal to 100 x 10^9/l 6. Neutrophils less than or equal to 1.0 x 10^9/ml
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Absolute change (demonstrated by significant difference) in plasma AUC of efavirenz alone or nevirapine alone if the respective 90% classical confidence interval for geometric mean ratio lies within 0.80 - 1.25 of the reference AUC 0 - 24 hours. All measures determined at the end of the study duration and data analysis (entire study duration is 8 days and data analysis approximately 3 weeks to a month). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Change in Cmax, Cmin, and weight-corrected apparent oral clearance (CL/F)/kg of efavirenz/nevirapine 2. Safety and tolerability of co-administration of clopidogrel and efavirenz/nevirapine All measures determined at the end of the study duration and data analysis (entire study duration is 8 days and data analysis approximately 3 weeks to a month). | — |
Countries
England, United Kingdom
Outcome results
None listed