PK Switch Efavirenz to Maraviroc in Patients Initially Suppressed on an Efavirenz-containing Regimen

• Status: Completed
• Trial end date: 2012-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the study aims is to help determine whether it is safe to change directly from efavirenz to maraviroc in patients who are stable on an efavirenz-containing regimen. The pharmacokinetics (drug levels) of efavirenz and maraviroc when efavirenz is stopped and maraviroc is started will be assessed.

Both the study patients and the study team will know which treatment is being taken at all times in the study.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: St Stephens Aids Trust
• Treatments: Efavirenz; Maraviroc

Criteria

Inclusion Criteria:

Subjects must meet all of the following inclusion criteria within 56 days prior to the baseline visit:

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 an 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 including a positive drugs of abuse test. (Note: a positive test for cannabinoids will not exclude the subject from the study).

Exclusion Criteria:

Subjects who meet any of the following exclusion criteria are not to be enrolled in this study.

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 Celsentri or components of NRTI backbone (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)