EFFECT OF THIENOPYRIDINE DERIVATIVE (CLOPIDOGREL) ON THE DISPOSITION OF EFAVIRENZ AND NEVIRAPINE IN HIV POSITIVE PATIENTS - Interaction between HIV drugs (NNRTIs) and Anti-platelet agent

Phase 1

• Conditions: To determine whether anti-platelet agent clopidigrel influences the disposition of NNRTIs (efavirenz and nevirapine)

• Registration Number: EUCTR2008-006371-67-GB
• Lead Sponsor: Royal Liverpool and Broadgreen University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-09-06
• Last Update Posted: 10 December 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 37

Inclusion Criteria

Inclusion Criteria

HIV positive
•Age 18 years and above
•On EFV or NVP containing regimen for greater or equal to 6 months
•Viral load less than or equal to 40 copies/ml and any CD4 count
•No Laboratory evidence of NNRTI toxicity : ALT =ULN; Bilirubin =ULN;Albumin =30g;Creatinine =ULN
•Not pregnant (for contraception, patients would be advised to use non-estrogen based contraceptive devices)
•No inter-current acute illness.
•No past medical history of coronary heart disease.
•No history of bleeding diathesis
•No history of allergy to thienopyridines
Exclusion Criteria
•Unable to provide informed consent
•Known or suspected poor adherence to ART
•Continuing IV drug user
•On HIV protease inhibitor or any known P450 inhibitors or inducers
•Neutrophils= 3.0 x 109/ml; HB 11.0g/dl
•Platelets = 100 x 109/l

Are the trial subjects under 18?
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years)
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

.Unable to provide informed consent
.Known or suspected poor adherence to ART
.Continuing IV drug user
.On a PI or any other known P450 inhibitors or inducers
.Platelets <100x109 L-1
.Neutrophils = 1.0 x 109/ml

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: We wish to determine whether the cardiac drug clopidogrel inhibit the metabolism of the HIV drugs Efavirenz and Nevirapine and therefore increase the concentration of these drugs (efavirenz and nevirapine) in the body. The implication of this is both to minimise the risk of toxicity, but also the potential to exploit these interactions with the view to influence new formulations of these agents (efavirenz and nevirapine) which would potentially be less toxic.;Secondary Objective: We wish to determine the safety of taking both efavirenz, nevirapine and cardiac drug clopidogrel in HIV patients, a scenario that is likely to become common with increasing survival of HIV patients. ;Primary end point(s): 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 h.