The Maraviroc Darunavir/Ritonavir Once Daily Pharmacokinetic Study
Condition: HIV
Intervention: Maraviroc; Truvada; Darunavir
Intervention description: Maraviroc 150 mg daily; daily until 10. day then stop; daily until 10. day then stop
Intervention MeSH terms: Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; Maraviroc; Darunavir
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 13.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: HIV

Summary:

      This is a phase I, open label, prospective, two phase pharmacokinetic study. Subjects
      currently attending for HIV care at St. Mary's Hospital, London will be eligible.
    

Eligibility criteria:

        Inclusion Criteria:

          -  HIV-1 infected males or females

          -  signed informed consent

          -  plasma HIV RNA < 50 copies/mL at screening and on at least one other occasion over the
             last 3 months

          -  currently receiving an antiretroviral regimen comprising of: tenofovir 245 mg
             daily,emtricitabine 200 mg daily, darunavir 800 mg daily and ritonavir 100 mg daily

          -  no previous protease inhibitor resistance documented on HIV-1 genotypic resistance
             testing if an HIV resistance test available

          -  Between 18 to 65 years of age, inclusive

          -  subjects in good health upon medical history, physical exam, and laboratory testing

          -  BMI above or equal to 18 and below 32

          -  Female subjects who are heterosexually active and of childbearing potential (i.e., not
             surgically sterile or at least two years post menopausal) must practice contraception
             as follows from screening until 8 weeks after completion of the study:

          -  barrier contraceptives (condom OR diaphragm PLUS spermicide) or oral, implant or
             injectable hormonal contraceptive PLUS a barrier contraceptive or

          -  IUD /IUS PLUS a barrier contraceptive

          -  Female subjects of childbearing potential must have a negative urine pregnancy test.

          -  Male subjects who are heterosexually active must use two forms of barrier
             contraception (e.g., condom with spermicide) during heterosexual intercourse, from
             screening through completion of the study.

          -  Have no serologic evidence of active HBV infection evidenced by negative hepatitis B
             surface antigen and no serologic evidence of hepatitis C virus infection evidenced by
             a negative HCV antibody at screening.

          -  Have screening laboratory results (haematology and chemistry that fall within the
             normal range of the central laboratory's reference ranges unless the results have been
             determined by the Investigator to have no clinical significance

          -  CCR5 tropic HIV virus based on a genotypic tropism assay from either a stored plasma
             sample where available or fresh plasma

        Exclusion Criteria:

          -  current alcohol abuse or drug dependence

          -  positive urine drug of abuse screening

          -  pregnancy

          -  active opportunistic infection or significant co-morbidities

          -  current disallowed concomitant medication