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

NCT01190293 | Completed Phase 4

• 1 other identifier: SSAT 033
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

HIV Infection

Outcome Measures

Primary Outcomes (1)

• Pharmocokinetics of maraviroc dosed at 600mg followed by 300mg thereafter following cessation of efavirenz 600mg.

  To assess the pharmacokinetics of maraviroc administered at 600mg twice-daily for 2 weeks to male and female HIV-1 infected patients who have achieved viral suppression on efavirenz-based therapy followed by maraviroc 300mg twice-daily until the end of the study.

  2 weeks

Secondary Outcomes (3)

• Virological suppression and CD4 rise

  4 weeks

• Safety and tolerability of an efavirenz to maraviroc switch.

  24 weeks

• Genetic influence

  24 weeks

Study Arms (1)

All subjects

EXPERIMENTAL

All Subjects will receive the same intervention.

Drug: Maraviroc

Interventions

Maraviroc DRUG

All patients (previously on an efavirenz-based therapy) will be administered maraviroc at 600mg twice-daily for 2 weeks.

Also known as: Efavirenz = Sustiva, Maraviroc = Celsentri

All subjects

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Males or non-pregnant, non-lactating females.
• Between 18 to 65 years, inclusive.
• Documented HIV-1 infection of at least 6 months duration.
• Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study.
• CD4 count \> 50 cells/mm3 at screening (Note retesting of screening CD4 count is allowed).
• 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).
• 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).
• R5-tropic virus as determined by genotypic assay performed at screening visit.
• 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).

You may not qualify if:

• Dual, mixed or X4-tropic virus on geno2pheno tropism sample
• HIV-2 co-infection
• Any prior CCR5 antagonists
• Any genotypic resistance to NNRTI or backbone NRTI on screening or prior tests (or likely from treatment history)
• Disallowed concomitant medication as per the SPC for Celsentri or components of NRTI backbone (see section 5.1.1)
• Any medical condition or psychiatric illness that may, in the opinion of the investigator, affect patient safety or the integrity of the results
• ALT or AST elevation greater than five times the upper limit of normal
• Estimated GFR (MDRD) less than 50ml/min

Sponsors & Collaborators

• St Stephens Aids Trust: lead

Study Sites (1)

St Stephen's Centre

London, SW109NH, United Kingdom

Location

Related Links

• (St Stephen's AIDS Trust website)

MeSH Terms

Conditions

HIV Infections

Interventions

Maraviroc; efavirenz

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Laura Waters, Dr

  St Stephen's AIDS Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2010
• First Posted: August 27, 2010
• Study Start: January 1, 2010
• Primary Completion: March 1, 2012
• Study Completion: March 1, 2012
• Last Updated: April 12, 2012

Record last verified: 2012-04

Locations

GB (1)