A pilot evaluation of the pharmacokinetics, efficacy and safety of switching from efavirenz to maraviroc administered at 600mg then 300mg twice-daily in patients suppressed on an efavirenz-containing regimen as initial therapy - Pharmacokinetics of switching from efavirenz to maraviroc

Phase 1

• Conditions: HIV

• Registration Number: EUCTR2009-014694-40-GB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-10-23
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 12

Inclusion Criteria

1.The ability to understand and sign a written informed consent form, prior to participation in any screening procedure and must be willing to comply with all study requirements.
2.Males or non-pregnant, non-lactating females.
3.Between 18 to 65 years, inclusive.
4.Documented HIV-1 infection of at least 6 months duration.
5.Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study.
6.CD4 count > 50 cells/mm3 at screening (Note retesting of screening CD4 count is allowed).
7.Receiving a first-line antiretroviral regimen including two NRTI with efavirenz, without any history of virological failure and agrees to remain on this regimen unless change is clinically indicated (history of drug switches is allowed only if the reason was tolerability/toxicity/convenience of dosing).
8.Viral load <50 copies/ml at screening and for at least 12 weeks prior to screening visit (Note retesting of screening viral load is allowed).
9.R5-tropic virus as determined by genotypic assay performed at screening visit.
10.No medical, psychiatric or substance misuse disorders felt by the investigator to impact on the subject’s ability to participate in the study.
Are the trial subjects under 18? no
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) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Dual, mixed or X4-tropic virus on geno2pheno tropism sample
2.HIV-2 co-infection
3.Any prior CCR5 antagonists
4.Any genotypic resistance to NNRTI or backbone NRTI on screening or prior tests (or likely from treatment history)
5.Disallowed concomitant medication as per the SPC for Truvada, Kivexa or Celsentri (see section 5.1.1)
6.Any medical condition or psychiatric illness that may, in the opinion of the investigator, affect patient safety or the integrity of the results
7.ALT or AST elevation greater than five times the upper limit of normal
8.Estimated GFR (MDRD) less than 50ml/min
9.Hepatitis B or C co-infection (defined as positive hepatitis B surface antigen or detectable hepatitis C RNA; hepatitis C antibody positive individuals with undetectable RNA will be eligible for inclusion)

Study & Design

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

Primary Outcome Measures

Name	Time	Method
<br> Secondary Objective: To assess the maintenance of the viral suppression and the rise in CD4 (marker of immune system) when switching efavirenz to maraviroc.<br><br> To assess the safety and tolerability of switching from efavirenz to maraviroc.<br> ;Primary end point(s): Steady state plasma concentrations of maraviroc dosed at 600mg BID for 2 weeks followed by 300mg BID thereafter following cessation of efavirenz 600mg OD.;Main Objective: To assess the pharmacokinetics (how a drug is absorbed, distributed and eliminated from the body) of maraviroc given at 600mg twice-daily for 2 weeks to male and female HIV-1 infected patients who have achieved viral suppression on an efavirenz-based therapy followed by 2 weeks of maraviroc 300mg twice-daily.